REadmissions, Adverse Complications and ouTcomes following Acute Myocardial Infarction Study (20 MINAP 03)

In term In term in the September 2026 edition: the latest version runs to 3 August 2029.

Reference: DARS-NIC-306651-W7L4C
Current version: v3.2
Term of current version: 8 August 2025 to 3 August 2029
Start date: 20 May 2021
Data controller: Sole Data Controller
Commercial purposes: No
Sublicensing: No
Files released to date: 82

Why the data was released

Objective for processing

Keele University requires access to NHS England data for the purpose of the following research project:

REadmissions, Adverse Complications and ouTcomes following Acute Myocardial Infarction Study (20 MINAP 03)

Acute myocardial infarction (AMI), also known as 'heart attack', remains a leading cause of morbidity and mortality in the United Kingdom and around the world. The acute survival of patients with AMI has improved significantly due to the wider use of stents, potent blood-thinning medications and improvements in preventive medications. Despite these advancements, the burden of complications such as stent blockage or narrowing and repeat heart attacks remain high in an increasingly ageing population. Although the use of newer treatments reduces the risk of future repeat heart attack events, it is often counterbalanced by the increased risk of significant bleeding complications.

Unplanned rehospitalisation is an undesired complication following index hospitalisation with AMI. (Index hospitalisation is the first time, in a series of hospitalisations, that a patient is admitted to a hospital for a specific condition or diagnosis.) Bleeding, further AMI, or heart failure are important causes of readmission, however significant proportions of readmissions are related to non-cardiac causes and inadequate treatment of and attention to other medical conditions during the index admission. Previous work using data from the United States has shown that almost one in ten patients with AMI are readmitted within 30 days, and over half of them are due to non-cardiac causes. However, the application of these findings to a national healthcare system such as the NHS is limited as the healthcare models in the United States are very different compared to the United Kingdom. Therefore, it is important to understand the incidence, predictors and causes of unplanned readmissions in the United Kingdom.

The REadmissions, Adverse Complications and ouTcomes following Acute Myocardial Infarction (REACT-AMI) study will assess the incidence of immediate and post-discharge complications in an unselected cohort of patients admitted with a diagnosis of AMI in the last 15 years. The prevalence and nature of subsequent cardiac and non-cardiac events such as readmission with further AMI, strokes, or other medical conditions will also be examined. This will allow the REACT-AMI team to identify the future risk of complications, determine which complications are associated with increased risk of dying or future AMI, and identify the risk factors associated with such complications. Using these risk factors, new risk scores could also be developed to predict future events and risk stratify patients presenting with AMI. This is extremely important and relevant for all doctors providing care to these patients as it will allow tailoring of treatment according to the patient baseline risk and risk of future cardiac and non-cardiac events.

The following is a summary of the aims of the research programme provided by or on behalf of Keele University:

• What are the current in-hospital and post-discharge complications rates following AMI, and how have these changed since 2004/05?

• What are the rates of 30-day unplanned readmissions following an AMI? What proportion of these are due to complications?

• Are there differences between rates of in-hospital and post-discharge complications between different types of AMI and what is their association with long term patient survival?

• How do individual complications vary amongst different subgroups of patients and their baseline risk?

• How does the clustering of comorbidities (simultaneous presence of two or more diseases or medical conditions in a patient) influence the initial care of the patient admitted with different types of AMI and are there differences in treatment which drive the incidence of subsequent complications?

• What are the different baseline clinical and pharmacological factors associated with the incidence of complications?

• How does the incidence of post-discharge complication vary geographically?

The primary outcome measure is the quantification of the incidence of post-discharge complications following AMI, and their association with all-cause and cardiac mortality at 30 days and 1-year follow-up. Secondary measures include the length of hospital stay, cause-specific repeat hospitalisation, major adverse cardiovascular events at 1-year follow-up, and unplanned readmissions within 30 days. The impact of post-discharge complications and unplanned readmissions on the long-term clinical outcomes for patients will also be studied.

The following NHS England Data will be accessed:

• Hospital Episode Statistics Admitted Patient Care (HES APC): Necessary to derive details of all demographics, diagnoses, procedures, admission, discharge dates, destinations of the patients. Major Adverse Cardiovascular Events will be derived from HES data using ICD-10 clinical diagnosis codes and cause of re-admissions.

• Civil Registrations of Death: Necessary to derive: Necessary to obtain information on post-discharge events.

• NICOR Myocardial Ischaemia National Audit Project (MINAP): Necessary to derive the cohort of patients diagnosed with Acute myocardial infarction (AMI).

The level of the Data will be Pseudonymised

The Data will be minimised as follows:

• Limited to a study cohort of all adult patients aged ≥18 years in the Myocardial Ischaemia National Audit Project (MINAP) registry

• Limited to admissions between 1st January 2005 and 31st December 2023.

• Baseline characteristics, in-hospital pharmacological treatment and in-hospital outcomes will be derived from the MINAP database.

Keele University is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The funding is provided by University Hospitals of North Midlands R&D. The funding is specifically for the project described. Funding is in place for the duration of the study.

No other organisations are involved in data processing or analysis. The REACT-AMI study team at Keele University has strong research collaborations with the University of Southampton and the University of Manchester, however, the research teams from these universities will not have any access to any record level data nor any role in determining the means by which the personal data are being processed. These research teams will collaborate in the interpretation of aggregated results data with small number suppression. They are not considered joint data controllers.

Processing activities

National Institute for Cardiovascular Outcomes Research (NICOR) data management team at NHS England will transfer data to the NHS England data provisioning team data will consist of identifying details: NHS number, Hospital ID, Date of Birth, Postcode, Gender & Date and time of admission derived from the NICOR Myocardial Ischaemia National Audit Project (MINAP) registry for the cohort to be linked with NHS England Civil Registrations of Death data and Hospital Episode Statistics Admitted Patient Care (HES APC).

The NHS England data provisioning team will provide the relevant records from the Civil Registrations of Death dataset and Hospital Episode Statistics Admitted Patient Care (HES APC) to National Institute for Cardiovascular Outcomes Research (NICOR) data management team at NHS England, who will then pseudonymise the data as requested before securely disseminating to the REACT-AMI study team at the Keele University. The Data will contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The Data will not be transferred to any other location.

The Data will be accessed onsite at the premises of Keele University and via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

The Data will not leave England/Wales at any time.

Access is restricted to employees or agents of Keele Universities REACT-AMI study team who have authorisation from the Principal Investigator.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will not be linked with any other data.

There will be no requirement and no attempt to reidentify individuals when using the Data.

Analysts/researchers from the REACT-AMI study team at Keele University will process/analyse the Data for the purposes described above.

Expected output

The study chief investigator is the deputy national audit lead for the National Institute for Cardiovascular Outcomes Research (NICOR) British Cardiac Intervention society. He is also a member of the NCAP (National Cardiovascular Audit Project) Operational and Methodology Group within NICOR. The findings of the study would be shared with the other audit leads, and if rates of unplanned readmissions were found to be significantly different between hospitals/ strategic health authority regions and the development of the risk score were to be successful, this would be implemented into national reporting by the group.

The main research findings will be presented on the Keele University webpages for the Keele Cardiovascular Research Group and the school of primary, social and community care in the form of news articles and press releases. Further dissemination of results and findings will be done via multiple sources such as Twitter, press releases, patient and public involvement (PPI) groups, particularly the patients representative groups that are part of the NICOR NCAP Operational and Methodology Group meetings that are held monthly, and national and international conferences and presentations. Furthermore, this work will be submitted for publications in peer-reviewed Journals soon after the analyses are completed.

Below are the publication output from the dataset so far.

1.Mohamed Dafaalla , Husam Abdel-Qadir , Chris P Gale , Louise Sun , Teresa López-Fernández , Robert J H Miller , Wojtek Wojakowski , James Nolan, Muhammad Rashid , Mamas A Mamas Outcomes of ST elevation myocardial infarction in patients with cancer; a nationwide study, Eur Heart J Qual Care Clin Outcomes. 2023 Mar 15:qcad012. doi: 10.1093/ehjqcco/qcad012

2. Mohamed Dafaalla , Francesco Costa , Haibo Jia , Harindra Wijeysundera, Muhammad Rashid , Michelle M. Graham, Wojtek Wojakowski, Alaide Chieffo , Gary Mintz , Mamas A. Mamas Ischemic and bleeding risk after ST-segment elevated myocardial infarction in patients with active cancer ( in submission).

3. Nicolas Weight, Muhammad Rashid, Mamas Mamas, Sex-based analysis of NSTEMI processes of care and outcomes by hospital: a nationwide cohort study ( in submission).

4. Muhammad Rashid, Dimtry Abramov, Mamas Mamas Incidence, Predictors of heart failure readmission following acute coronary syndrome in England and Wales, ( in submission).

4. Muhammad Rashid, Claire Lawson, GP McCann, Mamas Mamas, Readmission following Non- ST Elevation Acute myocardial Infarction, A Population cohort study (in review).

All results will be produced at an aggregated level rather than at the patient level. A statistical risk assessment will be completed for each publication of data and small number suppression techniques in line with the HES Analysis Guide will be used to ensure that analysis is not disclosive.

Expected measurable benefits

The findings of the REACT-AMI study could greatly improve local and national protocols of care provision for patients admitted with heart attacks. The benefit to patients and the public could be significant in several ways. Characterisation and developing a greater understanding of the prevalence, predictors and impact of the complications that occur following heart attack nationally is important, particularly to both patients and the wider NHS, given such complications have a significant impact on patient care and outcomes both in the short term and the long term. The development of new risk scores could facilitate clinicians in tailoring the treatment of patients according to the predicted risk. This is likely to confer benefits to patients presenting to hospitals with a heart attack as well as the treating physicians by improving risk stratification, balancing the risk and benefits of modern treatments of heart attack, identifying patients at risk of future complications, and guiding patient care provision to reduce the risk of repeat hospital admissions. Such risk scores may also form the basis of national reporting for benchmarking services, allowing expected risk-adjusted rates to be calculated.

All of the study findings will be reported to NICOR on an annual basis. NICOR are responsible for policy design and audit of care for patients admitted with heart attacks nationally. The risk stratification and other relevant findings such as causes of readmissions are expected to help policy-makers to implement measures to reduce the burden of readmission rates in this population. It is hoped that this will result in significant cost savings to the NHS by reducing the number of attendances to 'accident and emergency' and hospital admissions. For example, previous research work in the UK illustrates that unplanned readmissions occur in 9% of patients following a heart attack. It is therefore important to define the size of the problem in the UK, where cost and additional bed days are likely to be substantial in an overstretched National Health System. This might also allow policy makers to develop interventions to optimise care of these patients during index admission and implement pathways to reduce burden of re-admissions. From the patient point of view, it will be important for the patients to understand how different complications can affect their outcomes. This is hoped to help inform decision making when choosing between different treatment options. Furthermore, increased awareness in patients with heart attack may enable them to seek more appropriate medical care regarding minor and major complications post discharge.

Keele University's work are expected to provide important information relating to real-world outcomes, provide new information regarding optimal strategies to reduce the burden of complications, compare newer treatments/ strategies in the care provision of this cohort, particularly in areas/ patient groups where randomised controlled trials have not been undertaken. Publication of these findings in the academic journals/ international conferences are hoped to guide future research in this area such as those evaluating potent blood thinner medications, stents and procedural techniques to improve patient outcomes. For example, previous research work has demonstrated that bleeding complications and repeated heart attacks remain one of the most frequent adverse events after the index episodes. This programme of work will quantify the true extent of this problem in the UK population but will also compare different treatments which can potentially improve the care provision of these patients. Finally, this research will study patients’ outcomes who are otherwise not included in randomised control trials, such as those with different types of cancers, mental health conditions and other important comorbidities.

The requested data extract is essential for generating measurable benefits in the care and management of patients admitted with heart attacks, with implications for both clinical practice and healthcare policy. The REACT-AMI study aims to analyse the prevalence, predictors, and impact of complications following heart attacks across the UK, thereby enabling targeted interventions that could improve patient outcomes and reduce healthcare costs.

Measurable Benefits to Patients and Clinicians:

1. Development of Risk Scores for Tailored Treatment: By analysing the data, we aim to develop and validate new risk scores that will help clinicians tailor treatments based on a patient's specific risk profile. This could result in a measurable reduction in adverse events, such as bleeding complications or recurrent heart attacks, by at least 15-20% within the first year of implementation.

2. Reduction in Hospital Readmissions: Previous studies have shown that unplanned readmissions occur in approximately 9% of patients following a heart attack. By understanding the predictors and causes of these readmissions, we aim to develop targeted interventions that could reduce readmission rates by 25-30% over the next two years. This could result in a significant reduction in bed occupancy rates and a measurable decrease in NHS costs associated with emergency admissions.

3. Enhanced Patient Outcomes through Optimised Care Pathways: The research will provide evidence-based recommendations for optimising care pathways during the initial hospital admission, aiming to reduce the risk of complications by 20% and shorten the average length of hospital stays by 1-2 days for heart attack patients. This can be directly measured by comparing baseline data with post-implementation data.

4. National Benchmarking and Policy Development: The data extract will support the creation of risk-adjusted rates for benchmarking hospital performance at a national level. By providing NICOR (National Institute for Cardiovascular Outcomes Research) with annual data on risk stratification and readmission rates, we expect to see a measurable improvement in adherence to national guidelines and protocols across hospitals, with a target increase in guideline compliance by 15% over three years.

Measurable Benefits to Healthcare Systems:

5. Cost Savings for the NHS: By reducing the number of emergency attendances and subsequent admissions through targeted risk management and improved patient education, we anticipate potential cost savings of £5-10 million annually. This estimate is based on reduced bed occupancy, fewer emergency department visits, and fewer readmissions.

6. Improved Understanding of High-Risk Patient Groups: This research will also focus on patient subgroups typically underrepresented in clinical trials, such as those with comorbidities like cancer or mental health conditions. By quantifying outcomes in these populations, we aim to identify specific interventions that could improve outcomes by 10-15% over two years, as measured by reduced complication rates and mortality.

7. Guiding Future Research and Treatment Strategies: The findings from this study will be disseminated through academic publications and conferences, providing a basis for future clinical trials on advanced treatments (e.g., newer blood thinners, stents, and procedural techniques). The impact of these findings can be measured by subsequent research funding allocations, the number of follow-up studies initiated, and improvements in patient care metrics observed in pilot implementations.

Overall, the requested data extract will provide essential, measurable outcomes that could inform clinical practice, enhance patient care, reduce readmissions and costs, and guide national policy-making in heart attack care management.

Benefits reported so far

Keele University has reported the cause specific readmissions and complications in patients with cancer presenting with acute myocardial infarction. This has shown that STEMI patients with cancer have higher risk of short- and long-term mortality, particularly lung cancer. Colon cancer is the main cancer associated with major bleeding. Cardiovascular disease was the main cause of death in the first month whereas cancer was the main cause of death within one year.

Keele University now plans to extend this work into other phenotypes of acute myocardial infarction such as NSTEMI and unstable angina which will allow us to provide a complete picture about the treatment and outcomes of various cancer patients presenting with heart attacks. Keele University is also simultaneously, investigating the impact of other chronic conditions and complex disease such as Diabetes, heart failure and mental health disorders in patients presenting with heart attacks. using this information, we will to develop risk model to guide treatment and help clinicians in implementing treatment strategies to improve care of heart attack patients admitted to NHS.

Finally, qualification of readmissions and resulting costs will help to inform the burden of readmissions, develop interventions to reduce readmission and inform NHS recovery plan.

The following outputs have been generated from the study:

1. Socioeconomic disparities in the management and outcomes of acute myocardial infarction (DOI: 10.1136/heartjnl-2023-322601)

2. Ethnic Disparities in ST-Segment Elevation Myocardial Infarction Outcomes and Processes of Care in Patients With and Without Standard Modifiable Cardiovascular Risk Factors: A Nationwide Cohort Study (DOI: 10.1177/00033197231182555)

3. Trends in ST-elevation myocardial infarction hospitalization among young adults: a binational analysis (DOI: 10.1093/ehjqcco/qcad035)

4. Outcomes of ST elevation myocardial infarction in patients with cancer; a nationwide study (DOI: 10.1093/ehjqcco/qcad012)

5. Heart failure readmission in patients with ST elevation myocardial infarction and active cancer (DOI: 10.1016/j.jaccao.2023.10.011)

Additionally, the following manuscripts are currently under review:

1. Ischemic and bleeding risk after ST-segment elevated myocardial infarction in patients with active cancer

2. Quality of care and clinical outcomes following admission with an AMI in patients with cancer

3. CKD long-term outcomes and processes of care in patients with NSTEMI

4. Sex-based disparity in regional quality of care and outcomes in patients with AMI from England

5. Out-of-hospital cardiac arrest complicated by AMI: trends, readmissions, and long-term outcomes

6. Incidence, predictors of readmission, and complications in patients with AMI and cardiogenic shock

7. Long-term outcomes and processes of care for diabetes patients with NSTEMI

8. STEMI process of care across different regions of England over the last 15 years

Datasets on the current version

Legal basis for provision: Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Datasets approved under DARS-NIC-306651-W7L4C-v3.2
Dataset	Type of data	Sensitivity	Frequency	Confidential data
Civil Registrations of Death	Anonymised - ICO Code Compliant	Sensitive	One-Off	Section 251 NHS Act 2006
Civil Registrations of Death - Secondary Care Cut	Anonymised - ICO Code Compliant	Sensitive	One-Off	Section 251 NHS Act 2006
HES-ID to MPS-ID HES Admitted Patient Care	Anonymised - ICO Code Compliant	Non-Sensitive	One-Off	Section 251 NHS Act 2006
HES:Civil Registration (Deaths) bridge	Anonymised - ICO Code Compliant	Non-Sensitive	One-Off	Section 251 NHS Act 2006
Hospital Episode Statistics Admitted Patient Care (HES APC)	Anonymised - ICO Code Compliant	Non-Sensitive	One-Off	Section 251 NHS Act 2006
NICOR Myocardial Ischaemia National Audit Project (MINAP)	Anonymised - ICO Code Compliant	Non-Sensitive	One-Off	Section 251 NHS Act 2006

Files released

Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.

Patient opt-outs were applied to all 82 files released under this agreement, across every version. About opt-outs

No files recorded as released under the current version. 82 were released under earlier versions, shown in the version history.

Version history

The register lists each renewal of this agreement as a separate row. This site has 4 versions.

DARS-NIC-306651-W7L4C-v3.2 8 August 2025 to 3 August 2029

Title: REadmissions, Adverse Complications and ouTcomes following Acute Myocardial Infarction Study (20 MINAP 03)
Commercial: No
Sublicensing: No
Datasets: 6
Files released: 0

Datasets: Civil Registrations of Death; Civil Registrations of Death - Secondary Care Cut; HES-ID to MPS-ID HES Admitted Patient Care; HES:Civil Registration (Deaths) bridge; Hospital Episode Statistics Admitted Patient Care (HES APC); NICOR Myocardial Ischaemia National Audit Project (MINAP)

What changed from DARS-NIC-306651-W7L4C-v2.4

Text removed is ~~struck through~~; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-306651-W7L4C-v2.4
Field	Was	Became
Title	~~REadmissions, Adverse Complications and ouTcomes following Acute Myocardial Infarction Study~~	REadmissions, Adverse Complications and ouTcomes following Acute Myocardial Infarction Study (20 MINAP 03)
Start date	~~2024-10-07~~	2025-08-08
End date	~~2027-10-06~~	2029-08-03
Civil Registrations of Death: legal basis	~~National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
Civil Registrations of Death - Secondary Care Cut: legal basis	~~National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
HES-ID to MPS-ID HES Admitted Patient Care: legal basis	~~National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.
Hospital Episode Statistics Admitted Patient Care (HES APC): legal basis	~~National Health Service Act 2006 - s251 - 'Control of patient information'.~~	Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Datasets: + NICOR Myocardial Ischaemia National Audit Project (MINAP)

Objective for processing

Keele University requires access to NHS England data for the purpose of the following research project: REadmissions, Adverse Complications and ouTcomes following Acute Myocardial Infarction Study (20 MINAP 03) [3 paragraphs unchanged] ~~Keele University’s research questions are as follows:~~ The following is a summary of the aims of the research programme provided by or on behalf of Keele University: [8 paragraphs unchanged] The aim of this data application is to obtain pseudonymised record level Hospital Episode Statistics (HES) Admitted Patient Care (APC) and mortality data which provide the required post-index AMI discharge information to address the above research questions and outcome measures. The following NHS England Data will be accessed: This study will be a retrospective cohort study of all adult patients aged ≥18 years in the Myocardial Ischaemia National Audit Project (MINAP) registry admitted with a diagnosis of AMI between 1st January 2005 and 31st December 2023. Baseline characteristics, in-hospital pharmacological treatment and in-hospital outcomes will be derived from the MINAP database. • Hospital Episode Statistics Admitted Patient Care (HES APC): Necessary to derive details of all demographics, diagnoses, procedures, admission, discharge dates, destinations of the patients. Major Adverse Cardiovascular Events will be derived from HES data using ICD-10 clinical diagnosis codes and cause of re-admissions. To obtain information on post-discharge events and non-index hospital admissions, Hospital Episode Statistics (HES) Admitted Patient Care (APC) and mortality information will be requested. Record level information is required in order to be linked to the MINAP clinical data and understand the relationships between baseline characteristics/ comorbidities/ initial treatments and subsequent outcomes. The HES data contains details of all demographics, diagnoses, procedures, admission and discharge dates, and discharge destinations of the patients. Major Adverse Cardiovascular Events will be derived from HES data using ICD-10 clinical diagnosis codes and cause of re-admissions. • Civil Registrations of Death: Necessary to derive: Necessary to obtain information on post-discharge events. All readmission episodes up to the end of the study period will be obtained. The study will be undertaken in a national, pre-defined AMI cohort of unselected patients which pre-determines study size. The national reach of the data will allow studying the geographical variations in patient-related factors and hospital-level variations to elucidate how differences in treatments may be associated with complications/ readmissions. Given the extensive analyses and scale of research questions, the full 15 years of MINAP data is being requested for linkage to HES APC and mortality data. This will allow adjustment for all potential confounders, the performance of further sensitivity analyses and enough statistical power to address research questions effectively. • NICOR Myocardial Ischaemia National Audit Project (MINAP): Necessary to derive the cohort of patients diagnosed with Acute myocardial infarction (AMI). NHS Arden & Gem Commissioning Support Unit, on behalf of the National Institute for Cardiovascular Outcomes Research (NICOR), will provide the MINAP cohort identifiers to NHS England. Pseudonymised HES APC and mortality data will be returned to NICOR for linkage to the relevant MINAP clinical dataset. NICOR will ensure the linked dataset is fully pseudonymised before onward flow to Keele University. There are no alternative, less intrusive ways of achieving the purpose. The level of the Data will be Pseudonymised Keele University is the sole data controller for this study and will also be processing the data. Keele University’s General Data Protection Regulation (GDPR) Article 6 legal basis for the processing of the data is Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest. Processing of special category data is covered under GDPR Article 9(2)(j) which allows the processing of data for scientific research and statistical purposes. The Data will be minimised as follows: No other organisations are involved in data processing or analysis. The REACT-AMI study team has strong research collaborations with the University of Southampton and the University of Manchester, however, the research teams from these universities will not have any access to any record level data nor any role in determining the means by which the personal data are being processed. These research teams will collaborate in the interpretation of aggregated results data with small number suppression. They are not considered joint data controllers. • Limited to a study cohort of all adult patients aged ≥18 years in the Myocardial Ischaemia National Audit Project (MINAP) registry • Limited to admissions between 1st January 2005 and 31st December 2023. • Baseline characteristics, in-hospital pharmacological treatment and in-hospital outcomes will be derived from the MINAP database. Keele University is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above. The lawful basis for processing personal data under the UK GDPR is: Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller; The lawful basis for processing special category data under the UK GDPR is: Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject. The funding is provided by University Hospitals of North Midlands R&D. The funding is specifically for the project described. Funding is in place for the duration of the study. No other organisations are involved in data processing or analysis. The REACT-AMI study team at Keele University has strong research collaborations with the University of Southampton and the University of Manchester, however, the research teams from these universities will not have any access to any record level data nor any role in determining the means by which the personal data are being processed. These research teams will collaborate in the interpretation of aggregated results data with small number suppression. They are not considered joint data controllers.

Processing activities

~~Data flow:~~ National Institute for Cardiovascular Outcomes Research (NICOR) data management team at NHS England will transfer data to the NHS England data provisioning team data will consist of identifying details: NHS number, Hospital ID, Date of Birth, Postcode, Gender & Date and time of admission derived from the NICOR Myocardial Ischaemia National Audit Project (MINAP) registry for the cohort to be linked with NHS England Civil Registrations of Death data and Hospital Episode Statistics Admitted Patient Care (HES APC). NHS Arden & Gem Commissioning Support Unit, on behalf of the National Institute for Cardiovascular Outcomes Research (NICOR), will submit patient identifiers from the Myocardial Ischaemia National Audit Project (MINAP) to NHS England as follows: NHS number, study ID, date of birth, postcode and gender. Date of index acute myocardial infarction (AMI) admission will also be supplied. The NHS England data provisioning team will provide the relevant records from the Civil Registrations of Death dataset and Hospital Episode Statistics Admitted Patient Care (HES APC) to National Institute for Cardiovascular Outcomes Research (NICOR) data management team at NHS England, who will then pseudonymise the data as requested before securely disseminating to the REACT-AMI study team at the Keele University. The Data will contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient. ~~NHS England will return Hospital Episode Statistics (HES) Admitted Patient Care (APC), and Civil Registrations (Deaths) data to NHS Arden & Gem Commissioning Support Unit pseudonymised by study ID.~~ The Data will not be transferred to any other location. NICOR has designed security mechanisms that allow only authorised users to access information on the NICOR data collection and reporting system. Each audit database is accessed through a secure ID, the ID can be set to expire or have its access terminated, preventing unauthorised users from accessing the system. A complex password is required to access the ID and the password can be set to expire after a given period, forcing the user to change it regularly. Access to the database is controlled by a database Access Control List (ACL). This records when users have accessed data. Users and organisations only have access to their own records. All system database accesses are recorded in a system log file that can be audited in the event of suspected security threats or data misuse. The information recorded and managed by NICOR about patients and the clinical care they have received is confidential. Strict security measures are in place to safeguard patient information. The Data will be accessed onsite at the premises of Keele University and via remote access. The NICOR data management team (DMT) hosted by NHS Arden & Gem Commissioning Support Unit will link the HES APC and mortality data from NHS England with the associated clinical information from MINAP using the pseudonymised study ID number which cannot be used by Keele University to re-identify patients. The NICOR DMT are substantive employees of NHS Arden & Gem Commissioning Support Unit and are appropriately trained in data protection and confidentiality. The NICOR DMT will check the linked dataset for completeness, accuracy and consistency, and modify ‘date of death’ to ‘the number of days living since index admission’ and a yes/ no mortality status. This will further mitigate any risk of patient reidentification by Keele University. The pseudonymised linked clinical database will then be transferred to Keele University. There will be no further onward flows of record-level data. NICOR will retain record level NHS England data for a maximum of 12 months following linkage to the relevant MINAP clinical information. NICOR will retain record level data for this time in case there is any loss of data or in accuracies in final merged data extract. This will provide Keele University the opportunity to request a correction of the data in order that all necessary analyses can be undertaken. The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract. The data will be stored on the Keele University computer system with access restricted to substantive employees of Keele University for the purposes of the proposed project. There will be no requirement or attempt to re-identify individuals. Access to the Keele University computing resources is controlled by the University's Microsoft Active Directory through login IDs and passwords. Access to information assets is authorised by the Responsible Owner of the asset (the Information Guardian) and is granted by the Information Governance Lead (the Data Custodian). All information assets require a credential check on log in. All staff are fully trained in dealing with sensitive and confidential data, including their responsibilities to maintain patient confidentiality. Remote access to data is only allowed via a university secured laptop system via a secure VPN connection which is further protected by a secure authenticator password. For remote access: The data will be analysed by the REACT-AMI study team at Keele University. Exploratory analyses will quantify post-discharge complications, causes, and how these differ over baseline patient characteristics, types of heart attacks and time. The frequency of different types of complications, changes in frequency over time and association between different patient and hospital-related factors will be studied. All results will be produced at an aggregated level rather than at the patient level. A statistical risk assessment will be completed for each publication of data and small number suppression techniques in line with the HES Analysis Guide will be used to ensure that analysis is not disclosive. - Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA; - Access controls granting users the minimum level of access required are in place; - Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; - Multifactor authentication (MFA) is required for remote access; - Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; - All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy. The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose). The Data will not leave England/Wales at any time. Access is restricted to employees or agents of Keele Universities REACT-AMI study team who have authorisation from the Principal Investigator. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. The Data will not be linked with any other data. There will be no requirement and no attempt to reidentify individuals when using the Data. Analysts/researchers from the REACT-AMI study team at Keele University will process/analyse the Data for the purposes described above.

Expected output

[8 paragraphs unchanged] All results will be produced at an aggregated level rather than at the patient level. A statistical risk assessment will be completed for each publication of data and small number suppression techniques in line with the HES Analysis Guide will be used to ensure that analysis is not disclosive.

Benefits reported

~~The data controller~~ Keele University has reported the cause specific readmissions and complications in patients with cancer presenting with acute myocardial infarction. ~~For the first time, the data controller have~~ This has shown that STEMI patients with cancer have higher risk of short- and [26 words unchanged] month whereas cancer was the main cause of death within one year. ~~The data controller~~ Keele University now ~~plan~~ plans to extend this work into other phenotypes of acute myocardial infarction such [15 words unchanged] the treatment and outcomes of various cancer patients presenting with heart attacks. ~~The data controller are~~ Keele University is also simultaneously, investigating the impact of other chronic conditions and complex disease [32 words unchanged] treatment strategies to improve care of heart attack patients admitted to NHS. [1 paragraph unchanged] ~~Following~~ The following outputs have been generated from the ~~study~~ study: ~~Despite these challenges, we have made significant progress, evidenced by the following published outputs from the study:~~ [14 paragraphs unchanged]

Unchanged: Expected measurable benefits.

DARS-NIC-306651-W7L4C-v2.4 7 October 2024 to 6 October 2027

Title: REadmissions, Adverse Complications and ouTcomes following Acute Myocardial Infarction Study
Commercial: No
Sublicensing: No
Datasets: 5
Files released: 64

What changed from DARS-NIC-306651-W7L4C-v1.5

Text removed is ~~struck through~~; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Fields changed from DARS-NIC-306651-W7L4C-v1.5
Field	Was	Became
Start date	~~2024-04-21~~	2024-10-07
End date	~~2026-05-20~~	2027-10-06
Civil Registrations of Death - Secondary Care Cut: legal basis	~~Health and Social Care Act 2012 - s261 - 'Other dissemination of information'~~	National Health Service Act 2006 - s251 - 'Control of patient information'.
HES:Civil Registration (Deaths) bridge: legal basis	~~Health and Social Care Act 2012 - s261 - 'Other dissemination of information'~~	Not stated
Hospital Episode Statistics Admitted Patient Care (HES APC): legal basis	~~Health and Social Care Act 2012 - s261 - 'Other dissemination of information'~~	National Health Service Act 2006 - s251 - 'Control of patient information'.

Datasets: + Civil Registrations of Death; + HES-ID to MPS-ID HES Admitted Patient Care

Objective for processing

[4 paragraphs unchanged] • What are the current in-hospital and post-discharge complications rates following AMI, and how have these changed ~~over the past 15 years?~~ since 2004/05? [8 paragraphs unchanged] This study will be a retrospective cohort study of all adult patients [12 words unchanged] admitted with a diagnosis of AMI between 1st January 2005 and 31st ~~March 2020.~~ December 2023. Baseline characteristics, in-hospital pharmacological treatment and in-hospital outcomes will be derived from the MINAP database. [2 paragraphs unchanged] ~~Barts Health~~ NHS ~~Trust,~~ Arden & Gem Commissioning Support Unit, on behalf of the National Institute for Cardiovascular Outcomes Research (NICOR), will provide the MINAP cohort identifiers to NHS ~~Engalnd.~~ England. Pseudonymised HES APC and mortality data will be returned to NICOR for [21 words unchanged] University. There are no alternative, less intrusive ways of achieving the purpose. [2 paragraphs unchanged]

Processing activities

[1 paragraph unchanged] ~~Barts Health~~ NHS ~~Trust,~~ Arden & Gem Commissioning Support Unit, on behalf of the National Institute for Cardiovascular Outcomes Research (NICOR), will [26 words unchanged] Date of index acute myocardial infarction (AMI) admission will also be supplied. NHS England will return Hospital Episode Statistics (HES) Admitted Patient Care (APC), and Civil Registrations (Deaths) ~~Secondary Care Cut~~ data to ~~the Barts Health~~ NHS ~~Trust~~ Arden & Gem Commissioning Support Unit pseudonymised by study ID. [1 paragraph unchanged] The NICOR data management team (DMT) ~~at Barts Health~~ hosted by NHS ~~Trust~~ Arden & Gem Commissioning Support Unit will link the HES APC and mortality data from NHS England with [17 words unchanged] Keele University to re-identify patients. The NICOR DMT are substantive employees of ~~Barts Health~~ NHS ~~Trust~~ Arden & Gem Commissioning Support Unit and are appropriately trained in data protection and confidentiality. The NICOR DMT [122 words unchanged] of the data in order that all necessary analyses can be undertaken. [2 paragraphs unchanged]

Expected measurable benefits

[3 paragraphs unchanged] The requested data extract is essential for generating measurable benefits in the care and management of patients admitted with heart attacks, with implications for both clinical practice and healthcare policy. The REACT-AMI study aims to analyse the prevalence, predictors, and impact of complications following heart attacks across the UK, thereby enabling targeted interventions that could improve patient outcomes and reduce healthcare costs. Measurable Benefits to Patients and Clinicians: 1. Development of Risk Scores for Tailored Treatment: By analysing the data, we aim to develop and validate new risk scores that will help clinicians tailor treatments based on a patient's specific risk profile. This could result in a measurable reduction in adverse events, such as bleeding complications or recurrent heart attacks, by at least 15-20% within the first year of implementation. 2. Reduction in Hospital Readmissions: Previous studies have shown that unplanned readmissions occur in approximately 9% of patients following a heart attack. By understanding the predictors and causes of these readmissions, we aim to develop targeted interventions that could reduce readmission rates by 25-30% over the next two years. This could result in a significant reduction in bed occupancy rates and a measurable decrease in NHS costs associated with emergency admissions. 3. Enhanced Patient Outcomes through Optimised Care Pathways: The research will provide evidence-based recommendations for optimising care pathways during the initial hospital admission, aiming to reduce the risk of complications by 20% and shorten the average length of hospital stays by 1-2 days for heart attack patients. This can be directly measured by comparing baseline data with post-implementation data. 4. National Benchmarking and Policy Development: The data extract will support the creation of risk-adjusted rates for benchmarking hospital performance at a national level. By providing NICOR (National Institute for Cardiovascular Outcomes Research) with annual data on risk stratification and readmission rates, we expect to see a measurable improvement in adherence to national guidelines and protocols across hospitals, with a target increase in guideline compliance by 15% over three years. Measurable Benefits to Healthcare Systems: 5. Cost Savings for the NHS: By reducing the number of emergency attendances and subsequent admissions through targeted risk management and improved patient education, we anticipate potential cost savings of £5-10 million annually. This estimate is based on reduced bed occupancy, fewer emergency department visits, and fewer readmissions. 6. Improved Understanding of High-Risk Patient Groups: This research will also focus on patient subgroups typically underrepresented in clinical trials, such as those with comorbidities like cancer or mental health conditions. By quantifying outcomes in these populations, we aim to identify specific interventions that could improve outcomes by 10-15% over two years, as measured by reduced complication rates and mortality. 7. Guiding Future Research and Treatment Strategies: The findings from this study will be disseminated through academic publications and conferences, providing a basis for future clinical trials on advanced treatments (e.g., newer blood thinners, stents, and procedural techniques). The impact of these findings can be measured by subsequent research funding allocations, the number of follow-up studies initiated, and improvements in patient care metrics observed in pilot implementations. Overall, the requested data extract will provide essential, measurable outcomes that could inform clinical practice, enhance patient care, reduce readmissions and costs, and guide national policy-making in heart attack care management.

Benefits reported

[3 paragraphs unchanged] Following outputs have been generated from the study Despite these challenges, we have made significant progress, evidenced by the following published outputs from the study: 1. Socioeconomic disparities in the management and outcomes of acute myocardial infarction (DOI: 10.1136/heartjnl-2023-322601) 2. Ethnic Disparities in ST-Segment Elevation Myocardial Infarction Outcomes and Processes of Care in Patients With and Without Standard Modifiable Cardiovascular Risk Factors: A Nationwide Cohort Study (DOI: 10.1177/00033197231182555) 3. Trends in ST-elevation myocardial infarction hospitalization among young adults: a binational analysis (DOI: 10.1093/ehjqcco/qcad035) 4. Outcomes of ST elevation myocardial infarction in patients with cancer; a nationwide study (DOI: 10.1093/ehjqcco/qcad012) 5. Heart failure readmission in patients with ST elevation myocardial infarction and active cancer (DOI: 10.1016/j.jaccao.2023.10.011) Additionally, the following manuscripts are currently under review: 1. Ischemic and bleeding risk after ST-segment elevated myocardial infarction in patients with active cancer 2. Quality of care and clinical outcomes following admission with an AMI in patients with cancer 3. CKD long-term outcomes and processes of care in patients with NSTEMI 4. Sex-based disparity in regional quality of care and outcomes in patients with AMI from England 5. Out-of-hospital cardiac arrest complicated by AMI: trends, readmissions, and long-term outcomes 6. Incidence, predictors of readmission, and complications in patients with AMI and cardiogenic shock 7. Long-term outcomes and processes of care for diabetes patients with NSTEMI 8. STEMI process of care across different regions of England over the last 15 years

Unchanged: Expected output.

Objective for processing

Keele University’s research questions are as follows:

• What are the current in-hospital and post-discharge complications rates following AMI, and how have these changed since 2004/05?

• What are the rates of 30-day unplanned readmissions following an AMI? What proportion of these are due to complications?

• Are there differences between rates of in-hospital and post-discharge complications between different types of AMI and what is their association with long term patient survival?

• How do individual complications vary amongst different subgroups of patients and their baseline risk?

• What are the different baseline clinical and pharmacological factors associated with the incidence of complications?

• How does the incidence of post-discharge complication vary geographically?

The aim of this data application is to obtain pseudonymised record level Hospital Episode Statistics (HES) Admitted Patient Care (APC) and mortality data which provide the required post-index AMI discharge information to address the above research questions and outcome measures.

This study will be a retrospective cohort study of all adult patients aged ≥18 years in the Myocardial Ischaemia National Audit Project (MINAP) registry admitted with a diagnosis of AMI between 1st January 2005 and 31st December 2023. Baseline characteristics, in-hospital pharmacological treatment and in-hospital outcomes will be derived from the MINAP database.

To obtain information on post-discharge events and non-index hospital admissions, Hospital Episode Statistics (HES) Admitted Patient Care (APC) and mortality information will be requested. Record level information is required in order to be linked to the MINAP clinical data and understand the relationships between baseline characteristics/ comorbidities/ initial treatments and subsequent outcomes. The HES data contains details of all demographics, diagnoses, procedures, admission and discharge dates, and discharge destinations of the patients. Major Adverse Cardiovascular Events will be derived from HES data using ICD-10 clinical diagnosis codes and cause of re-admissions.

All readmission episodes up to the end of the study period will be obtained. The study will be undertaken in a national, pre-defined AMI cohort of unselected patients which pre-determines study size. The national reach of the data will allow studying the geographical variations in patient-related factors and hospital-level variations to elucidate how differences in treatments may be associated with complications/ readmissions. Given the extensive analyses and scale of research questions, the full 15 years of MINAP data is being requested for linkage to HES APC and mortality data. This will allow adjustment for all potential confounders, the performance of further sensitivity analyses and enough statistical power to address research questions effectively.

NHS Arden & Gem Commissioning Support Unit, on behalf of the National Institute for Cardiovascular Outcomes Research (NICOR), will provide the MINAP cohort identifiers to NHS England. Pseudonymised HES APC and mortality data will be returned to NICOR for linkage to the relevant MINAP clinical dataset. NICOR will ensure the linked dataset is fully pseudonymised before onward flow to Keele University. There are no alternative, less intrusive ways of achieving the purpose.

Keele University is the sole data controller for this study and will also be processing the data. Keele University’s General Data Protection Regulation (GDPR) Article 6 legal basis for the processing of the data is Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest. Processing of special category data is covered under GDPR Article 9(2)(j) which allows the processing of data for scientific research and statistical purposes.

No other organisations are involved in data processing or analysis. The REACT-AMI study team has strong research collaborations with the University of Southampton and the University of Manchester, however, the research teams from these universities will not have any access to any record level data nor any role in determining the means by which the personal data are being processed. These research teams will collaborate in the interpretation of aggregated results data with small number suppression. They are not considered joint data controllers.

Expected output

Below are the publication output from the dataset so far.

3. Nicolas Weight, Muhammad Rashid, Mamas Mamas, Sex-based analysis of NSTEMI processes of care and outcomes by hospital: a nationwide cohort study ( in submission).

4. Muhammad Rashid, Dimtry Abramov, Mamas Mamas Incidence, Predictors of heart failure readmission following acute coronary syndrome in England and Wales, ( in submission).

4. Muhammad Rashid, Claire Lawson, GP McCann, Mamas Mamas, Readmission following Non- ST Elevation Acute myocardial Infarction, A Population cohort study (in review).

Benefits reported

The data controller has reported the cause specific readmissions and complications in patients with cancer presenting with acute myocardial infarction. For the first time, the data controller have shown that STEMI patients with cancer have higher risk of short- and long-term mortality, particularly lung cancer. Colon cancer is the main cancer associated with major bleeding. Cardiovascular disease was the main cause of death in the first month whereas cancer was the main cause of death within one year.

The data controller now plan to extend this work into other phenotypes of acute myocardial infarction such as NSTEMI and unstable angina which will allow us to provide a complete picture about the treatment and outcomes of various cancer patients presenting with heart attacks. The data controller are also simultaneously, investigating the impact of other chronic conditions and complex disease such as Diabetes, heart failure and mental health disorders in patients presenting with heart attacks. using this information, we will to develop risk model to guide treatment and help clinicians in implementing treatment strategies to improve care of heart attack patients admitted to NHS.

Finally, qualification of readmissions and resulting costs will help to inform the burden of readmissions, develop interventions to reduce readmission and inform NHS recovery plan.

Following outputs have been generated from the study

Despite these challenges, we have made significant progress, evidenced by the following published outputs from the study: