Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 51
- 主要终点
- Death from any cause
研究概览
简要总结
The purpose of this study is to determine whether ICD(Implantable Cardioverter Defibrillator) implantation on the top of optimal medical therapy in patients with variant angina manifesting as aborted sudden cardiac death reduces the incidence of the death from any cause compared with optimal medical therapy alone.
详细描述
All participants will be monitored over a span of five years and the time point of the year of last subject last visit. The term "year of last subject last visit" refers to the time point of the last visit for all participants. At this specific time point, event occurrence check will be conducted to determine the occurrence of endpoint events among all participants.
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
- None
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
- •Age 18 years or older
- •Patients experienced successfully resuscitated cardiac arrest due to documented ventricular fibrillation or sustained rapid ventricular tachycardia
- •Diagnosed as variant angina, defined by spontaneous coronary spasm with ST elevation (≥0.1mV) in the coronary angiogram and/or documented coronary spasm on ergonovine provocation coronary angiography
排除标准
- •Significant (>50%) coronary artery stenosis on coronary angiography
- •Organic heart disease known to be associated with sudden cardiac arrest.
- •Heart failure with reduced ejection fraction (Left Ventricular Ejection Fraction < 35%)
- •Presence of LV akinesia or aneurysm
- •Hypertrophic cardiomyopathy
- •Arrhythmogenic right ventricular dysplasia
- •Chronic Heart Failure New York Heart Association functional class III or IV
- •prior history of atrial or ventricular arrhythmia requiring class I or III antiarrhythmic drugs (flecainide, propafenone, amiodarone, sotalol and dronedarone)
- •Prior catheter ablation for ventricular arrhythmia
- •Primary cardiac electrical diseases (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia)
- •Prior pacemaker or Implantable Cardioverter Defibrillator
- •2nd or 3rd degree AV block not related to coronary ischemia, requiring permanent pacemaker
- •Patients with poor neurologic outcome (defined as cerebral performance category scale ≥3)
- •Life expectancy <2 years
- •Psychiatric illnesses that may be aggravated by device implantation or that may preclude systematic follow-up
研究组 & 干预措施
optimal medical therapy
干预措施: Optimal Medical Therapy (Drug)
ICD implantation and optimal medical therapy
干预措施: Implantable Cardioverter Defibrillator (Device)
结局指标
主要结局
Death from any cause
时间窗: 5 years
次要结局
- Event rate of Cardiac death(5 years)
- Event rate of Hospitalization(5 years)
- Event rate of Inappropriate ICD therapies(5 years)
- Event rate of Major device-related complications(5 years)
- Event rate of Recurrence of ventricular tachyarrhythmia(5 years)
- Event rate of Death from arrhythmia(5 years)
- Event rate of Cardiac arrest(5 years)
- Event rate of Appropriate ICD therapies(5 years)
- Event rate of Stroke(5 years)
研究者
Kee-joon Choi
professor of medicine
Asan Medical Center