Continuous Rhythm Monitoring in Patients After Acute Myocardial infaRction and pREServed Left venTricle Ejection Fraction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Ventricular fibrillation
研究概览
简要总结
The trial will inform whether detection of ventricular arrhythmias by means of implantable loop recorder (ILR) can help to predict SCD in the large population of survivors of a myocardial infarction with preserved left ventricular function, EF>40%. This may improve risk stratification in these patients, and can inform on the clinical use of subcutaneous monitors to identify post-infarction populations in need for an intervention to prevent sudden death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed
- •Documented myocardial infarction in the 7days prior to enrolment
- •Age > 18 yrs
- •Left ventricular ejection fraction >=40% as assessed by echocardiography within 7 days window after MI.
排除标准
- •subject is unwilling or unable to comply with the study procedures
- •documented ventricular tachycardia or survived cardiac arrest outside of an acute coronary syndrome
- •Subject has indications for active implanted cardiac medical device (IPG, ICD, CRT).
- •contraindications for implantation of a ICM - Planned CABG procedure
结局指标
主要结局
Ventricular fibrillation
时间窗: 24 months
Cardiac arrest
时间窗: 24 months
Documented Arrhythmic death without evidence of primary non cardiac cause
时间窗: 24 months
Sustained, nonsustained, symptomatic, asymptomatic ventricular tachycardias
时间窗: 24 months
Atrial Fibrillation (symptomatic and asymptomatic)
时间窗: 24 months
次要结局
- Changing in treatment strategy, based on physician decision(24 months)
- CV events(24 months)
- Invasive procedures for arrhythmia treatment(24 months)
- All Arrhythmic events recorded by ILR(24 months)
- Changing in medical treatment (anticoagulation, antiarrhythmic drugs)(24 months)