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

Recruiting now · Phase 4

Conditions studied: Angina Pectoris, Variant, Sudden Cardiac Death

In brief

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.

Key facts

Study ID

NCT02845531

Run by

Kee-joon Choi

People needed

140

Starts

2016-11-29

Expected to finish

2031-06-01

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ajou University Hospital — Suwon, South Korea (enrolling)
• Busan National University Yangsan Hospital — Busan, South Korea (enrolling)
• Seoul university Bundang hospital — Seongnam, South Korea (enrolling)
• Asan Medical Center — Seoul, South Korea (enrolling)
• Ewha Womans University Mokdong Hospital — Seoul, South Korea (enrolling)
• Kangdong KyungHee University hospital — Seoul, South Korea (enrolling)
• Korea University Anam Hospital — Seoul, South Korea (enrolling)
• Seoul National University Boramae Medical Center — Seoul, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Soon Chun Hyang University Hospital Bucheon — Bucheon-si, South Korea (enrolling)
• Dong-A Medical Center — Busan, South Korea (enrolling)
• Keimyung University Dongsan Medical Center — Daegu, South Korea (enrolling)
• Chungnam National University Hospital — Daejeon, South Korea (enrolling)
• Chonnam National University Hospital — Gwangju, South Korea (enrolling)
• Inje University Ilsan Paik Hospital — Ilsan, South Korea (enrolling)
• Gachon University Gil Medical Center — Incheon, South Korea (enrolling)
• Chonbuk National University Hospital — Jeonju, South Korea (enrolling)
• Chungnam National University Sejong Hospital — Sejong, South Korea (enrolling)
• Busan University Hospital — Busan, South Korea
• Severance Hospital — Seoul, South Korea
• Soon Chun Hyang University Hospital Cheonan — Cheonan, South Korea
• Korea University Guro Hospital — Seoul, South Korea
• The Catholic Univ. of Korea, Seoul St. Mary's Hospital — Seoul, South Korea
• Gangneung Asan Hospital — Gangneung, South Korea
• The Catholic University of Korea, Eunpyeong St. Mary's Hospital — Seoul, South Korea

Full record on ClinicalTrials.gov

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