Safety and feasibility of triage and rapid discharge of patients with chest pain from emergency room: a pragmatic, randomised non-inferiority control trial of the European Society of Cardiology (ESC) 0–1 hour pathway vs. conventional 0-3 hour accelerated diagnostic protocol.

Liverpool University Hospitals NHS Foundation Trust requires access to NHS England data for the purpose of the following research project:

Safety and feasibility of triage and rapid discharge of patients with chest pain from emergency room: a pragmatic, randomised non-inferiority control trial of the European Society of Cardiology (ESC) 0–1 hour pathway vs. conventional 0-3 hour accelerated diagnostic protocol.

The following is a summary of the aims of the research project provided by/on behalf of Controller:

The current practice in Liverpool University Hospital Foundation Trust is to take a blood sample when the patient presents to accident and emergency and then to repeat this after 3 hours. If the blood tests detect a rise in the troponin levels, then the patient is likely to have suffered a heart attack. It is also possible to repeat the test at 1 hour rather than 3 hours. The advantage of this is potentially shortening the patients stay in the emergency department. Recent evidence from the High Sensitivity Cardiac Troponin T assay for rapid Rule-out of Acute Myocardial Infarction (TRAPID-AMI) study suggests that this is just as safe and facilitate safe discharge of more patients. The evidence has persuaded the European Society of Cardiology to include this in their 2020 guidelines.

However, what is not clear is how well this new pathway (the 0/1-hour pathway- taking a blood sample at presentation and after 1 hour from presentation) works in practice in a busy and stressful department. It is possible due to time constraints that the repeat sample at 1 hour would be too difficult to work in practice.

The study purpose is to introduce the 0/1-hour pathway in Liverpool University Hospital Foundation Trust, which is approved for use, but at the same time the primary objective of this study is to understand if, in practice, it performs better than the current 0/3-hour pathway being used.

The principal outcome measure will be the safety of the 0-1 hour protocol (which is less established and has limited data on safety when implemented in clinical practice)

The following NHS England Data will be accessed:

• Hospital Episode Statistics

o Admitted Patient Care – necessary to inform whether a patient presented to another acute hospital within 30 days of presentation.

The level of the Data will be:

• Identifiable

The Data will be minimised as follows

• Limited to a study cohort identified by Controller – a cohort of 3751 consented participants.

The Liverpool University Hospitals NHS Foundation Trust 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 comes from multiple sources. Current funders include:

• Innovation agency

• Liverpool University Hospital NHS Foundation Trust

• Menarini UK,

• Abbott Diagnostics

• Liverpool University hospital NHS FT. Charities, General cardiology fund

• Quidel Cardiovascular Inc

• Siemens Healthcare Diagnostics Limited.

• Personal research Funds Dr Aleem Khan.

Funding to continue the work described will be sought on an ongoing basis.

The funders will have no ability to suppress or otherwise limit the publication of findings.

This research project is funded partly by commercial organisations. The manufacturers (Siemens and Quidel) of the two novel point of care assays, being tested, have provided funding to the study. Both will be looking to use the data that is published, independently as evidence to get NICE approval in the UK for their devices.

Liverpool University Hospitals NHS Foundation Trust will transfer data to NHS England.

The data will consist of identifying details NHS Number, Date of Birth and Study ID for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES APC dataset to Liverpool University Hospital NHS Foundation Trust. The Data will

• contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient

The Data will not be transferred to any other location.

The Data will be stored on servers at Liverpool University Hospital NHS foundation trust.

The Controller 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 the UK at any time.

Remote processing will be from secure locations within the UK. The data will not leave the UK at any time.

Access is restricted to employees or agents of Liverpool University Hospital NHS Foundation Trust. who have authorisation from the Principal Investigator.

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

The aggregated information derived from the Data will be combined with aggregated data from the REDCAP database.

Researchers from the Liverpool University hospital NHS Foundation trust will analyse the Data for the purposes described above.

This is the largest RCT comparing two rapid diagnostic algorithms in the diagnosis of myocardial infarction. It will provide a concrete analysis of the safety of both pathways and will inform clinicians world wide of the benefits and potential draw backs of one algorithm over another. By getting this data Liverpool University Hospitals NHS Foundation Trust will be able to provide an adjudicated 30 day major adverse cardiac event rate for any participant presenting to anywhere in the country.

This RCT on completion will be submitted to peer review journals. The methodology protocol paper was recently accepted to the American Heart Journal for publication. The Controller will also submit abstracts for presentation at the European Society of Cardiology Conference in 2025. The results will inform later guidelines issued by the European and American Societies of Cardiology and is likely to inform NICE guidance. It will also guide the local practice of the Accident and Emergency departments in the local NHS hospital trust.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

Abbott Diagnostics has developed an Articifical Intelligence algorithm to predict the chance of a heart attack in those presenting to A+E with chest pain. Abbott Diagnostics will receive an anonymised data set from Liverpool University NHS Foundation Trust which consists of clinical research number, the timing of 1st blood sample and result, timing of the second blood sample and result and patient outcome (heart attack occurred or not).

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practices to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

The Study will greatly enhance knowledge of the safety of the 0/1hour against the 0/3 hour algorithm for the rule out of myocardial infarction. It will be the largest randomised controlled trial in this space.

The Study will inform policy makers including European and American Societies of Cardiology and NICE. Not only on use of such algorithms but also clinical performance of two novel point of care high-sensitivity troponin assays.

The direct result of this work will be that Liverpool University Hospitals NHS Foundation Trust is able to create a change of practice in the Accident and Emergency departments locally and nationally. Enabling faster discharge of patients without compromising on patient safety.

It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

Not stated in the register.