The characterisation of patients with takotsubo cardiomyopathy from the Myocardial Ischaemia National Audit Project (MINAP)

Imperial College London requires access to NHS England data for the following research study:

The characterisation of patients with takotsubo cardiomyopathy from the Myocardial Ischaemia National Audit Project (MINAP)

Imperial College London is conducting research to better understand Takotsubo Cardiomyopathy (TCM), a heart condition that often mimics a heart attack. TCM mostly affects post-menopausal women and is triggered by emotional stress, physical illness, or sometimes for no clear reason. When someone experiences TCM, they often feel sudden chest pain and show ECG results similar to a heart attack, which leads doctors to begin emergency treatment. However, when they perform a coronary angiogram (a scan of the heart’s blood vessels), they find no blockages, meaning the usual treatment to restore blood flow isn’t needed. The heart’s unusual shape and movement in TCM usually return to normal within a few weeks.

The following is a summary of the aims of the research study provided by or on behalf of Imperial College London:

• Address the evidence gap by studying TCM in large populations, which has been limited due to:

- Its temporary nature

- Difficulty detecting it with one-off heart scans

- Limited representation in existing biobanks

• Use NHS data to:

- Estimate how frequently TCM occurs

- Identify contributing or associated factors

• Investigate potential influences, including:

- Emotional or physical stress triggers

- Family history of cardiac conditions

- Hormonal imbalances

- Co-existing health conditions (e.g. thyroid disorders, mental health issues)

- Early signs of heart dysfunction

- Medication use

- Cardiac imaging findings

• Generate insights to:

- Inform future research in genetics and cardiac imaging

- Support the development of more personalised and effective treatments for individuals with TCM

The following NHS England Data will be accessed:

• NICOR Myocardial Ischaemia National Audit Project (MINAP) - necessary because the NICOR MINAP dataset captures survey data on patients discharged with a diagnosis of TCM. It directly supports the study’s aims by providing essential information on prevalence, triggers, family history, and hormonal factors.

The level of the Data will be Pseudonymised.

The Data will be minimised as follows:

• Limited to a study cohort identified by NHS England as meeting the following criteria: all individuals discharged with a diagnosis of TCM from the MINAP dataset from 01/01/2010 until the latest available (~3,000 individuals).

• A set of matched control individuals from the MINAP dataset (no TCM survey information will be available on these individuals).

Imperial College London 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.

This processing is in the public interest because the results of the analyses will inform the NHS of the prevalence of this condition in the UK. It will also bring attention to the current management practices and will serve as a basis for future research designed to prevent and improve patient outcomes.

The funding will be provided by charities (the British Heart Foundation and Sir Jules Thorn Charitable Trust). The funding is specifically for the study described.

Imperial College London is the sole data controller.

Data access is limited to substantive employees of Imperial College London within the Cardiovascular Genomics and Precision Medicine Group.

Patient and Public Involvement and Engagement (PPIE) for this study was initiated through informal conversations at the Cardiomyopathy UK annual meeting. During these discussions, individuals affected by Takotsubo Cardiomyopathy (TCM) voiced a strong desire for increased research into their condition, which directly inspired the launch of this study. The research team is now actively inviting TCM patients to participate via the Heart Hive platform (https://thehearthive.org/), a dedicated portal designed to connect patients with a broad spectrum of cardiovascular research initiatives. Through Heart Hive, participants can contribute by completing surveys, sharing personal insights, and providing genetic data — all of which will help advance understanding and drive future discoveries in the field.

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide the relevant records from the MINAP dataset to Imperial College London. 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 stored on servers at Imperial College London.

The Data will be backed-up on a separate server at Imperial College London.

The Data will be accessed onsite at the premises of Imperial College London 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 the UK at any time.

Access is restricted to Substantive Employees of Imperial College London within the Cardiovascular Genomics and Precision Medicine Research Group.

Collaborating organisations to the Cardiovascular Genomics and Precision Medicine Lab (MRC Laboratory of Medical Sciences, Imperial College Healthcare hospitals and the Royal Brompton & Harefield hospitals) are not permitted to access the data disseminated under this agreement.

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.

Researchers from Imperial College London will process the Data for the purposes described above.

The expected outputs of the processing will be:

• Submission to a peer-reviewed journals, a year after data access.

• Presentation at European or British Society of Cardiology conferences

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.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Journals, with sharing of published research on social media and via university and charity websites such as the British Heart Foundation website.

• Presentation at European or British Society of Cardiology conferences.

The research team aims to publish findings within one year of accessing the dataset, targeting early 2027 for initial submission. As peer-reviewed journal publication typically takes up to a year from submission to final release, the anticipated publication date is by the end of 2027.

The findings from this analysis are expected to deliver substantial benefits for the NHS by addressing critical gaps in the understanding and management of Takotsubo Cardiomyopathy (TCM). Despite its clinical significance, current knowledge of TCM - including its underlying causes, contributing factors, and associated diagnoses - remains limited, and there are no standardised treatment pathways. As the largest study of its kind, this research will establish the prevalence of TCM, identify key emotional and physiological triggers, and examine patient characteristics, clinical management strategies, early left ventricular dysfunction, and recurrence patterns. The insights gained will enhance awareness and understanding of TCM across patients, families, clinicians, and researchers, supporting more accurate diagnosis and personalised care. Importantly, the data will empower patients with clearer information about their condition, inform the development of a dedicated TCM patient cohort, and lay the foundation for future research into targeted therapies and improved outcomes.

Collaboration is in place with Cardiomyopathy UK and the British Heart Foundation, and the publication will be shared with both organisations to support wider dissemination of the findings.

Yielded Benefits is not a requirement for new applications.