Ventricular Arrhythmias in the Acute Phase of Myocardial Infarction: ADVERSE MI Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 8
- 主要终点
- Post-discharge mortality
研究概览
简要总结
Ventricular arrhythmias are a serious complication of myocardial infarction. The aim of this study is to provide reliable data on the management and mortality associated with ventricular arrhythmia in the setting of acute myocardial infarction.
详细描述
Ventricular arrhythmias remain a major complication during the acute phase of myocardial infarction. The 2022 European guidelines on ventricular arrhythmias recommend implantable cardioverter-defibrillator (ICD) placement for secondary prevention when ventricular fibrillation occurs ≥ 48 hours after the infarct. Yet this recommendation rests on limited evidence. We therefore conduct a multicentre retrospective study to characterise the clinical profile, management, and prognosis of sustained ventricular arrhythmias (ventricular tachycardia and ventricular fibrillation) arising in the acute myocardial infarction setting.
The primary objective of this study is to evaluate post-discharge mortality in patients who develop an arrhythmia either within 48 hours of, or more than 48 hours after, an acute myocardial infarction. Sensitivity analyses will further examine outcomes according to the arrhythmia subtype (ventricular fibrillation vs ventricular tachycardia), the presence of concomitant heart failure, and the myocardial-infarction phenotype (STEMI vs NSTEMI).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years
- •Acute myocardial infarction
- •Sustained ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation) at the acute phase of an acute myocardial infarction (before hospital discharge)
- •Between January 1, 2012 and April 14, 2024
排除标准
- 未提供
研究组 & 干预措施
Ventricular arrhythmia
patients who developed a sustained ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation) during the acute phase of myocardial infarction, i.e., from infarct onset to hospital discharge
结局指标
主要结局
Post-discharge mortality
时间窗: through study completion, an average of 2 years
次要结局
- Rate of defibrillator implantation during hospitalization and after hospital discharge(through study completion, an average of 2 years)
- Number of participants, incidence, characteristics, and management of electrical storms(At baseline)
- Baseline demographic and clinical characteristics at inclusion(At baseline)
- Number of participants fot each type of myocardial infarction(At baseline)
- Number of participants with each ventricular arrhythmia characteristic and management strategy during index hospitalization(At baseline)
- In-hospital mortality(From admission until the date of death or hospital discharge, whichever came first, assessed up to 28 days)
- Number of participants with wearable cardioverter-defibrillator utilization(At baseline)
- Rate of recurrent myocardial infarction after hospital discharge(through study completion, an average of 2 years)
- Rate of recurrent ventricular arrhythmias after hospital discharge(through study completion, an average of 2 years)