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

SUdden death Risk eValuatIon and VulnErability post-Myocardial Infarction

Registry ID
ISRCTN17193826
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
University of Leicester
Enrollment
57
Start date
2026-04-30
Completion date
2029-09-02
Last update
2026-08-17

Conditions

Summary

Sudden cardiac death following myocardial infarction

Detailed description

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.

Interventions

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

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

Locations

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