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

Sponsor

Kee-joon Choi (Other)

Overall Status

Recruiting

CT.gov ID

NCT02845531

Collaborator

CardioVascular Research Foundation, Korea (Other)

140

Enrollment

Locations

Arms

Anticipated Duration (Months)

5.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Angina Pectoris, Variant Sudden Cardiac Death	Device: Implantable Cardioverter Defibrillator Drug: Optimal Medical Therapy	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Actual Study Start Date :

Nov 29, 2016

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ICD implantation and optimal medical therapy	Device: Implantable Cardioverter Defibrillator Implantable Cardioverter Defibrillator and Optimal Medical Therapy
Active Comparator: optimal medical therapy	Drug: Optimal Medical Therapy

Arm

Intervention/Treatment

Experimental: ICD implantation and optimal medical therapy

Device: Implantable Cardioverter Defibrillator

Implantable Cardioverter Defibrillator and Optimal Medical Therapy

Active Comparator: optimal medical therapy

Drug: Optimal Medical Therapy

Outcome Measures

Primary Outcome Measures

Death from any cause [5 years]

Secondary Outcome Measures

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 [5 years]
Hospitalization due to unstable angina, acute myocardial infarction, heart failure, cardiac arrhythmia
Event rate of Appropriate ICD therapies [5 years]
Appropriate ICD therapies defined as device-administered antitachycardia or defibrillation treatment for ventricular tachyarrhythmia that had not terminated spontaneously
Event rate of Inappropriate ICD therapies [5 years]
Event rate of Major device-related complications [5 years]
Event rate of Stroke [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Soon Chun Hyang University Hospital Bucheon	Bucheon	Korea, Republic of
2	Busan National University Yangsan Hospital	Busan	Korea, Republic of
3	Busan University Hospital	Busan	Korea, Republic of
4	Dong-A Medical Center	Busan	Korea, Republic of
5	Soon Chun Hyang University Hospital Cheonan	Cheonan	Korea, Republic of
6	Keimyung University Dongsan Medical Center	Daegu	Korea, Republic of
7	Chungnam National University Hospital	Daejeon	Korea, Republic of
8	Gangneung Asan Hospital	Gangneung	Korea, Republic of
9	Chonnam National University Hospital	Gwangju	Korea, Republic of
10	Wonkwang University Hospital	Iksan	Korea, Republic of
11	Gachon University Gil Medical Center	Incheon	Korea, Republic of
12	Chonbuk National University Hospital	Jeonju	Korea, Republic of
13	Chungnam National University Sejong Hospital	Sejong	Korea, Republic of
14	Seoul university Bundang hospital	Seongnam	Korea, Republic of
15	Asan Medical Center	Seoul	Korea, Republic of
16	Ewha Womans University Mokdong Hospital	Seoul	Korea, Republic of
17	Kangdong KyungHee University hospital	Seoul	Korea, Republic of
18	Korea University Anam Hospital	Seoul	Korea, Republic of
19	Korea University Guro Hospital	Seoul	Korea, Republic of
20	Seoul National University Boramae Medical Center	Seoul	Korea, Republic of
21	Seoul National University Hospital	Seoul	Korea, Republic of
22	Severance Hospital	Seoul	Korea, Republic of
23	The Catholic Univ. of Korea, Seoul St. Mary's Hospital	Seoul	Korea, Republic of
24	The Catholic University of Korea, Eunpyeong St. Mary's Hospital	Seoul	Korea, Republic of
25	Ajou University Hospital	Suwon	Korea, Republic of