RecruitingObservational

Sudden cardiac death risk evaluation using personalised electrophysiological, autonomic and mental health assessment following myocardial infarction

After a heart attack, some people are at risk of their heart suddenly stopping, known as sudden cardiac arrest. Currently, it's hard to accurately predict who needs a special device (an ICD) to prevent this. This study wants to create a more accurate test to identify those truly at risk, preventing unnecessary surgery for some and ensuring others who need help aren't missed. Researchers are also investigating if feelings like sadness or worry can affect heart stability. By combining new heart assessment technology (LifeMap) with understanding mental health, this study hopes to improve predictions, explore new treatments, and ultimately save lives by making sure heart attack survivors get the most appropriate care.

At a glance

Status

Recruiting

Sponsor

University of Leicester

Enrolment target

Start

30 Apr 2026

Estimated completion

02 Mar 2027

Sudden cardiac death following myocardial infarction

What is this study about?

When someone has a heart attack, their heart muscle can be damaged. For most, their heart continues to work well, but for a small number of people, this damage can lead to an 'electrical short circuit' that makes the heart suddenly stop beating, which is very dangerous. Doctors have a device, called an ICD, that can be placed inside the body during surgery. If the heart short-circuits, the ICD delivers an electric shock to get it beating normally again.

Right now, it's difficult for doctors to precisely know who is at high risk of a future 'short circuit' and therefore who truly needs an ICD. The existing tests aren't accurate enough, meaning some people might have surgery for an ICD they don't really need, while others who could benefit are missed. This study aims to create a much better and more individualised test to predict this risk. The researchers believe that looking at a combination of factors, including new ways to measure the heart's electrical activity and even a person's mental well-being, could provide a clearer picture. They suspect that stress or anxiety might influence how stable the heart is.

By taking part, you would be helping researchers develop a more accurate and affordable way for healthcare professionals to identify those who truly need a life-saving ICD device. The study also hopes to understand if improving mental health and reducing worry could actually help protect the heart. Ultimately, this research aims to lay the groundwork for new treatments and ensure that heart attack survivors receive the most appropriate and effective care.

Key takeaways

New study to improve prediction of sudden cardiac arrest after a heart attack.
Aims to ensure only those who truly need an ICD device receive one.
Explores how mental well-being might affect heart stability.
Uses a new computer test, LifeMap, to assess individual heart risk.
Based at the University of Leicester and funded by The Kusuma Trust.
Participation could help improve care for future heart attack patients.

Who may be eligible?

This study is looking for two main groups of people. Firstly, they need participants who are over 18 and have recently had a specific type of heart attack (STEMI) within the last 40 days to 3 months. Secondly, they are also looking for healthy volunteers, aged 18 and over, who have never had heart problems.

There are also some reasons why you might not be able to take part. For heart attack survivors, this includes having other specific heart conditions (like certain inherited conditions or atrial fibrillation), if your health outlook is severely limited, or if you are unable to safely take part in exercise tests. For healthy volunteers, you wouldn't be able to join if you have a history of any heart diagnosis or surgery, or if you can't safely complete the required exercise tests. Everyone taking part must be over 18 and able to understand and agree to the study independently.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 18 years old?
Have you had a heart attack (specifically STEMI) between 40 days and 3 months ago, or are you a healthy volunteer with no heart problems?
Are you able to understand and consent to participating in a study independently?
Are you able to safely perform exercise tests?
Do you have any other significant heart conditions (e.g., inherited heart diseases, atrial fibrillation) that might exclude you?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study involves several assessments. You'll undergo tests that measure your heart's electrical signals and other signals from your nerves, using a new computer tool called LifeMap. This helps assess your individual risk of a 'short circuit' in your heart. You'll also be asked about your feelings and mental well-being through questionnaires, to see if sadness or worry might affect your heart and nervous system. The study includes exercise tests, where you might be asked to temporarily pause any heart rate-altering medications you are taking, under medical guidance. The study is expected to run from April 2026 to September 2029, and your involvement would contribute to this overall timeline.

Potential risks and benefits

Participating in this study could help improve future medical tools, potentially leading to better prediction and prevention of sudden cardiac arrest for others. This could mean fewer unnecessary ICD procedures for some and ensuring those who truly need an ICD receive one. The research also aims to provide new insights into the link between mental health and heart recovery. As with any medical procedure, there are some potential risks. Exercise tests are generally safe, but rarely, they could lead to changes in heart rhythm, fainting, or blood pressure drops. Temporarily stopping heart medications for the tests can sometimes cause minor side effects like headaches, tiredness, or a temporary rise in blood pressure. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Leicester
Unverified
Leicester, England

Common questions

What is an ICD?

An ICD is a small device, similar to a pacemaker, that surgeons place under your skin, usually in your chest. If your heart develops a dangerous electrical 'short circuit,' the ICD can deliver an electrical shock to reset it and get it beating normally again, potentially saving your life.

What is a 'heart short circuit'?

After a heart attack, the heart muscle can be damaged. Sometimes, this damage can disrupt the heart's normal electrical signals, causing it to beat very rapidly and chaotically, or even stop. This is what the study refers to as an 'electrical short circuit,' which can lead to sudden cardiac arrest.

Who is funding this research?

This important research is being funded by The Kusuma Trust, UK.

Will taking part affect my regular medication?

For some exercise tests, you might be asked to temporarily pause heart rate-altering medications. This will be done under careful medical supervision, and is usually well-tolerated, but potential side effects from stopping medication will be discussed with you.

How can I find out more or get involved?

You can get in touch with the main contact for the study, Dr Edward Lau, via email at el203@leicester.ac.uk, to learn more or discuss potential participation.

How to find out more

Edward Lau

el203@leicester.ac.uk +44 0116 373 6508 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.