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

ISRCTN	ISRCTN17193826
DOI	https://doi.org/10.1186/ISRCTN17193826
Integrated Research Application System (IRAS)	355700
Protocol number	1083
Sponsor	University of Leicester
Funder	The Kusuma Trust

Submission date: 20/04/2026
Registration date: 23/04/2026
Last edited: 20/04/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
After a person has a heart attack, their heart is damaged. For most people, their hearts keep working fine. But for a small group, this damage can cause an electrical "short circuit." This makes the heart stop beating suddenly, which causes death. Doctors have a device called an ICD that can be put inside a person’s chest during surgery. If the heart short-circuits, this ICD device shocks it back to life. Currently, it is unknown how to precisely measure the danger of a short circuit to decide who needs an ICD device. The tests used to decide who needs an ICD device are not accurate enough. This means that many people get surgery who don't need it, and others who need it are missed. This happens because of missing Information, where researchers have not been looking at all the right signs, and one size doesn’t fit all, instead of using general rules. The project goal is to create a better test to predict who is in danger, and to understand if a patient's sadness or anxiety might keep their heart stable.

By looking at the heart and the brain, this study hopes to:
• Develop an accurate and affordable test to tell healthcare professionals who need a life-saving ICD device.
• See if helping people feel happier and less worried can actually protect their hearts
• Set up future studies looking at new treatments which keep the heart stable.

Who can participate?
Patients aged over 18 who are post-MI, with STEMI within 40 days to 3 months, and healthy volunteers aged 18 and over.

What does the study involve?
Measuring individual risk
A new computer test has been created called LifeMap. It can directly measure the risk of a short circuit in the heart for each person. There are also tools to check the electrical signals in the nerves. It is thought that "stress messages" from the brain travel down these nerve wires. These messages might make the heart unstable, increasing the chance of a dangerous short circuit - something that LifeMap allows us to measure.

Check the Short Circuit Risk:
• The study will compare heart signals after a heart attack with healthy hearts using the LifeMap computer test to measure the electrical stability of patients’ following a heart attack whilst measuring the impacts of signals from the brain and nerves.
• To understand feelings and mental health, patients will be asked about their mental health to see if feeling sad or worried makes their heart and nerves more unstable and prove that this can be measured.

What are the possible benefits and risks of participating?
Participation will aid in improving medical risk tools, including the LifeMap technology, potentially leading to better prediction and prevention of sudden cardiac death (SCD) for future patients. Aiming to reduce unnecessary ICD insertion and find those who would benefit from an ICD and currently would not be offered one. Much of the work planned is under-researched and the results of the study aim to provide new information to the scientific community, including links between mental health and recovery after a heart attack.

As with any medical procedure, there are some risks and possible side effects. Exercise tests are generally a very safe procedure and serious complications are rare, but can include fast or slow heart rhythms, fainting and falls in blood pressure. Participants will be asked to pause heart rate-altering medicines for the exercise tests. Stopping these medications for a short period is usually well tolerated; however, some withdrawal side effects can occur, such as headache, tiredness and a rise in blood pressure.

Where is the study run from?
University of Leicester, UK.

When is the study starting and how long is it expected to run for?
April 2026 to September 2029.

Who is funding the study?
The Kusuma Trust, UK.

Who is the main contact?
Dr Edward Lau, el203@leicester.ac.uk

Contact information

Dr Edward Lau
Scientific, Public, Principal investigator

University of Leicester
Leicester
LE1 7RH
United Kingdom

ORCID ID	0000-0002-9640-3343
Phone	+44 0116 373 6508
Email	el203@leicester.ac.uk

Prof G André Ng
Principal investigator, Scientific

University of Leicester
Leicester
LE1 7RH
United Kingdom

ORCID ID	0000-0001-5965-0671
Phone	+44 0116 373 6508
Email	andre.ng@leicester.ac.uk

Dr Will Nicolson
Scientific

Glenfield Hospital
Leicester
LE3 9QP
United Kingdom

ORCID ID	0000-0002-5718-8767
Phone	+44 0300 303 157
Email	will.nicolson@nhs.net

Dr Xin Li
Scientific

University of Leicester
Leicester
LE1 7RH
United Kingdom

ORCID ID	0000-0002-4018-6220
Phone	+44 0116 373 6508
Email	xin.li@leicester.ac.uk

Dr Sarah Gunn
Scientific

University of Leicester
Leicester
LE1 7RH
United Kingdom

ORCID ID	0000-0002-8492-060X
Phone	+44 0116 373 6508
Email	sarah.gunn@leicester.ac.uk

Study information

Primary study design	Observational
Observational study design	Cohort study
Scientific title	SUdden death Risk eValuatIon and VulnErability post-Myocardial Infarction
Study acronym	SURVIVE-MI
Study objectives	The primary objective is investigating the performance of LifeMap sudden cardiac death risk using non-invasive measures Key research questions: • Can autonomic and cardiac restitution differences be measured between infarcted versus healthy myocardium • Understanding the effect of different exercise modalities and regimens on cardiac electrophysiological measures including non-invasive LifeMap measures • What is the impact of mental health on autonomic and cardiac restitution and is this different between infarcted versus healthy myocardium • To what extent does post-MI cardiac dysfunction impact anxiety and depression • Does comorbid anxiety or depression in post-MI patients represent a distinct "higher-risk phenotype" that warrants consideration in risk tools • Can we measure how changes in the autonomic nervous system including severity of anxiety and depression link to cardiac electrical instability and sudden cardiac death risk.
Ethics approval(s)	Approved 03/02/2026, London South East REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 0207 104 8000; londonsoutheast.rec@hra.nhs.uk), ref: 26/LO/0063
Health condition(s) or problem(s) studied	Sudden cardiac death following myocardial infarction
Intervention	Suitable patients following MI will be approached alongside controls without cardiac disease to participate in the prospective cohort study. All participants will attend a treadmill exercise study and be given a 24-hour ECG monitor; subgroups will be determined based on left ventricular ejection fraction. Electrogram and exercise data will be compared between post-MI participants and controls. Validated questionnaires will measure baseline symptoms and demographics, including anxiety and depression burden, quality of life, health literacy and autonomic symptom burden. Subgroups of the post-MI participants will be invited to focus groups to understand the lived experience following acute MI. Control arm participants will complete the stationary bike exercise test to compare electrophysiological, exercise and LifeMap outcomes between exercise modalities and regimens.
Intervention type	Other
Primary outcome measure(s)	Assess if Non-Invasive LifeMap metric (R2I2) is elevated in patients following MI compared to healthy controls and the impact of LVEF measured using Exercise Electrocardiogram at 40 days - 3 Months Following MI
Key secondary outcome measure(s)	Predictive capacity of cardiac autonomic dysfunction and NI-LifeMap measured using SCD Mortality event at 12 Months Explore the measurability of autonomic differences by severity of anxiety and depression and association with cardiac electrical instability measured using Electrocardiogram at 40 days - 3 Months Following MI Determine the Relative Autonomic symptom burden, Anxiety symptom burden, Depressive symptom burden, quality of Life, and health literacy levels in the post-MI cohort measured using questionnaire data at 40 days - 3 Months Following MI Explore the association of mental health with adverse cardiovascular outcomes measured using composite endpoint of SCD, non-arrhythmic cardiovascular event, non-fatal MI and hospitalisation at 12 months Understand the lived experiences of individuals with anxiety following acute MI measured using focus groups at less than 12 months post MI Assess the impact of mental health symptom burden on healthcare interaction and compliance measured using symptom burden seen on questionnaire data with community prescription dispensing and secondary care records at 12 months Assess the reproducibility and quality of non-invasive LifeMap measures and QT dynamics measured using treadmill and bike exercise at 40 days - 3 Months Following MI Assess QT dynamics of post MI patients compared to healthy controls measured using Electrocardiogram at 40 days - 3 Months Following MI Assess the effect of rate of change of HR change on the QT relationship measured using Electrocardiogram at 40 days - 3 Months Following MI Assess the heart rate recovery relationship with cardiac events and measures of autonomic dysfunction measured using Exercise Electrocardiogram at 40 days - 3 Months Following MI Assess the risk stratification of non-invasive LifeMap to predict outcomes compared to current guidelines measured using SCD events at 12 Months Assess SCD events in relation to cardiac autonomic dysfunction and non-invasive LifeMap measured using Electrocardiogram and study measurements at 12 Months
Completion date	02/09/2029

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	57
Key inclusion criteria	Post-MI Inclusion Criteria 1. Patients aged over 18 2. STEMI within 40 days to 3 months Control Inclusion Criteria 1. Over the age of 18 2. Able to consent to the study independently 3. Considered to be fit enough to be able to complete the full repeat measure exercise protocol
Key exclusion criteria	Post-MI Exclusion Criteria 1. Diagnosis of a non-ischemic cardiomyopathy 2. Inherited cardiac conditions which have an increased risk of SCD, including inherited structural diseases and channelopathies 3. Presence of severe comorbid conditions limiting life expectancy to less than 1 year 4. Contraindications to exercise study 5. Inability to consent to the study 6. Atrial fibrillation 7. Planned or outstanding coronary percutaneous or surgical revascularisation 8. Deemed unable to participate in an exercise study targeting achievement of maximal heart rate , based on existing functional or symptomatic limitations 9. Inability to understand written and verbal English to enable safe participation on dynamic exercise testing Control Exclusion Criteria 1. Previous cardiac diagnosis including acute coronary syndrome/cardiac surgery, angina, severe valvular heart disease, arrhythmia 2. Previous cardiac intervention including Implanted pacemaker, cardiac surgery 3. Deemed unable to participate in an exercise study targeting achievement of maximal heart rate , based on existing functional or symptomatic limitations 4. Contraindications to exercise study 5. Inability to understand written and verbal English to enable safe participation on dynamic exercise testing
Date of first enrolment	30/04/2026
Date of final enrolment	02/03/2027

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Leicester

Glenfield Hospital
Groby Road
Leicester
LE3 9QP
England

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

20/04/2026: Study's existence confirmed by Health Research Authority (HRA) (UK).