An observational study in Sudden Death, Cardiac, Myocardial Scarring and Myocardial Infarction (MI), sponsored by Beijing Anzhen Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Beijing Anzhen Hospital · Observational
The purpose of this observational study is to investigate whether myocardial scar characteristics assessed by cardiac magnetic resonance (CMR) can predict the risk of out-of-hospital sudden cardiac death (SCD) after myocardial infarction (MI). It aims to answer two primary questions:
What is the association between CMR-assessed myocardial scar and post-MI SCD? Can we develop an imaging-clinical multimodal risk score for post-MI SCD? Participants included in this study had previously undergone CMR imaging during the stable phase following their MI as part of their prior clinical care. Prognostic data for these participants are collected through clinic visits and telephone follow-up.
Sudden cardiac death (SCD) remains a leading cause of mortality post-myocardial infarction (MI). Current risk stratification relying primarily on left ventricular ejection fraction (LVEF ≤35%) for implantable cardioverter-defibrillator (ICD) therapy is inadequate, as many SCD events occur in patients with LVEF >35%. Myocardial scar characteristics assessed by cardiac magnetic resonance (CMR), particularly late gadolinium enhancement (LGE), show promise for improved arrhythmic risk prediction but require robust validation. This study aims to develop and validate a multimodal clinical-CMR risk prediction model integrating comprehensive scar characterization to better identify high-risk post-MI patients who may benefit from ICD therapy, optimizing prevention strategies and resource utilization.
This single-center, ambispective cohort study comprises two phases. Phase 1 (Retrospective): Patients treated for myocardial infarction (MI) at our institution between 2015 and 2025 were screened retrospectively. Those who underwent CMR imaging at least one month post-MI were included. Baseline clinical characteristics and detailed CMR findings were collected. Prognostic data for these patients were retrospectively gathered through January 2026.
Phase 2 (Prospective): Prospective collection of prognostic data for the enrolled cohort will continue from 2026 through 2036. Follow-up will be conducted primarily via clinic visits and telephone interviews at 6-month intervals.
Endpoint Definitions:
Primary Endpoint: Sudden cardiac death (SCD)-equivalent events, encompassing:
SCD events;Aborted SCD events (successful resuscitation from cardiac arrest or ventricular arrhythmia);Appropriate implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) therapies for terminating ventricular tachyarrhythmias.
Secondary Endpoints:
Include all-cause mortality, cardiovascular mortality, heart failure rehospitalization, recurrent myocardial infarction, and composite endpoints thereof.
314 studies on the registry are indexed under Death, Sudden, Cardiac; 80 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 500 across 172 observational studies indexed under Death, Sudden, Cardiac.
Browse Death, Sudden, Cardiac studies →Beijing Anzhen Hospital is the lead sponsor of 188 studies on the registry; 100 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Chinese patients with myocardial infarction (MI).
Exclusion Criteria:
Participants included in this study had previously undergone CMR imaging during the stable phase following their MI as part of their prior clinical care.
Sudden cardiac death (SCD)-equivalent events
Primary Endpoint: Sudden cardiac death (SCD)-equivalent events, encompassing: SCD events: cardiac death occured in a short time period (2 hour of symptom), which were assessed by two separated doctors from the central laboratory. Aborted SCD events (successful resuscitation from cardiac arrest or ventricular arrhythmia): patients with ventricular tachycardia, ventricular fibrillation or sudden cardiac arrest who were saved by cardio-pulmonary resuscitation and electric defibrillation. Appropriate implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) therapies for terminating ventricular tachyarrhythmias: Shock related events were analyzed by two separated experienced electrophysiology doctor,to identify if the shock is delivered by sustained ventricular tachycardia, ventricular fibrillation and sudden cardiac death.
Time frame: 10-20 years
Secondary Outcome
Include all-cause mortality, cardiovascular mortality, heart failure rehospitalization, recurrent myocardial infarction, and composite endpoints thereof.
Time frame: 10-20 years
Plan to share: No
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Beijing Anzhen Hospital