Comprehensive Cardiac Magnetic Resonance Imaging Evaluation of Myocardial Scar for Predicting Sudden Cardiac Death Post Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Sudden cardiac death (SCD)-equivalent events
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years.
- •Completion of cardiac magnetic resonance (CMR) imaging at Anzhen Hospital during the stable phase (≥1 month) following an acute myocardial infarction (MI).
排除标准
- •Prior implantation of an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) before the index MI.
- •Pre-existing diagnosis of a primary arrhythmia syndrome (e.g., long QT syndrome, Brugada syndrome) before the index MI.
- •Concurrent end-stage disease (e.g., advanced malignancy) directly resulting in an estimated life expectancy of less than one year.
- •History of established non-ischemic cardiomyopathy (e.g., dilated, hypertrophic, or restrictive cardiomyopathy) before the index MI.
- •Significant concomitant valvular heart disease. Status post mechanical heart valve replacement.
- •Patients refuse to be followed up.
结局指标
主要结局
Sudden cardiac death (SCD)-equivalent events
时间窗: 10-20 years
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.
次要结局
- Secondary Outcome(10-20 years)