Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
Overview
- Phase
- Phase 4
- Intervention
- Implantable Cardioverter Defibrillator
- Conditions
- Angina Pectoris, Variant
- Sponsor
- Kee-joon Choi
- Enrollment
- 140
- Locations
- 25
- Primary Endpoint
- Death from any cause
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Kee-joon Choi
professor of medicine
Asan Medical Center
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Arms & Interventions
ICD implantation and optimal medical therapy
Intervention: Implantable Cardioverter Defibrillator
optimal medical therapy
Intervention: Optimal Medical Therapy
Outcomes
Primary Outcomes
Death from any cause
Time Frame: 5 years
Secondary Outcomes
- 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)