Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death

Study 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.

Conditions
-----------------
Angina Pectoris, Variant, Sudden Cardiac Death

Intervention / Treatment
-----------------
* Device: Implantable Cardioverter Defibrillator
* Drug: Optimal Medical Therapy


Participation Criteria
=================
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) 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICD implantation and optimal medical therapy<br> | Device: Implantable Cardioverter Defibrillator<br>* Implantable Cardioverter Defibrillator and Optimal Medical Therapy<br>|
| Active Comparator: optimal medical therapy<br> | Drug: Optimal Medical Therapy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from any cause |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event rate of Cardiac death |  | 5 years | 
| Event rate of Death from arrhythmia |  | 5 years | 
| Event rate of Cardiac arrest |  | 5 years | 
| Event rate of Recurrence of ventricular tachyarrhythmia |  | 5 years | 
| Event rate of Hospitalization | Hospitalization due to unstable angina, acute myocardial infarction, heart failure, cardiac arrhythmia | 5 years | 
| Event rate of Appropriate ICD therapies | Appropriate ICD therapies defined as device-administered antitachycardia or defibrillation treatment for ventricular tachyarrhythmia that had not terminated spontaneously | 5 years | 
| Event rate of Inappropriate ICD therapies |  | 5 years | 
| Event rate of Major device-related complications |  | 5 years | 
| Event rate of Stroke |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Variant angina, Aborted sudden cardiac death, Implantable Cardioverter Defibrillator, Optimal Medical Therapy, ICD