Vest Prevention of Early Sudden Death Trial: Prevention of Sudden Death After Myocardial Infarction Using a LifeVest Wearable Cardioverter-defibrillator (Formerly VEST/PREDICTS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,348
- 试验地点
- 138
- 主要终点
- Sudden Death Mortality
研究概览
简要总结
This study explores the hypothesis that wearable defibrillators can impact mortality by reducing sudden death during the first three months after a heart attack in persons with high risk for life-threatening arrhythmias.
详细描述
In patients with ventricular dysfunction immediately following myocardial infarction, sudden death may be responsible for up to 50% of total mortality. Wearable defibrillators may reduce sudden death by providing immediate detection and treatment of ventricular arrhythmias. This study is design to demonstrate a reduction in sudden death measured at three months following myocardial infarction among patients who have ventricular dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Patients identified in the hospital or within 7 days after discharge with a diagnosis of an acute MI (STEMI or Non-STEMI)
- •LV ejection fraction ≤35% determined at the following time point:
- •If no PCI within the first 8 hours following the MI: ≥ 8 hours after MI
- •If acute PCI occurs within 8 hours of MI: ≥8 hours after PCI
- •If CABG is planned (before or within 7 days of discharge), wait to enroll and then use the most recent assessment at least 48 hours post CABG
- •Age ≥ 18 years
排除标准
- •Existing ICD or indication for an ICD at the time of screening
- •Existing unipolar pacemakers/leads
- •Chronic renal failure requiring hemodialysis after hospital discharge
- •Chest circumference too small or too large for LifeVest garment*
- •Participants discharged to an institutional setting with an anticipated stay > 7 days
- •Pregnancy
- •Inability to consent
- •Any other condition or circumstance that in the judgment of the clinician makes the participant unsuitable for the study.
结局指标
主要结局
Sudden Death Mortality
时间窗: three months after myocardial infarction
For witnessed deaths, sudden cardiac death will be defined as an unexpected non-traumatic, non-self-inflicted fatality in otherwise stable participants who die within one hour of the onset of the terminal symptoms. For unwitnessed deaths, participants will meet the definition of sudden death if they are found dead within 24 hours of being well, assuming there is no evidence of another cause of death during that time period.
次要结局
- All Cause Mortality(three months after myocardial infarction)
- Compliance With Wearable Defibrillator Use(three months after myocardial infarction)