Tests defibrillator implants added to medicine for variant angina patients
Tests a heart defibrillator plus medicine versus medicine alone in adults with variant angina.
Plain-language title generated from the registry record
Registry title: Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
Key facts
- Where
- Bucheon-si, Busan, Cheonan, Daegu, Daejeon, Gangneung, Gwangju, Iksan, Ilsan, Incheon, Jeonju, Sejong, Seongnam, Seoul, and Suwon, South KoreaSee the 26 sites
- Phase
- Phase 4
Where in South Korea
- Soon Chun Hyang University Hospital BucheonBucheon-si, South KoreaTaking people
- Busan National University Yangsan HospitalBusan, South KoreaTaking people
- Dong-A Medical CenterBusan, South KoreaTaking people
- Busan University HospitalBusan, South KoreaNo longer taking part
- Soon Chun Hyang University Hospital CheonanCheonan, South KoreaNo longer taking part
- Keimyung University - Dongsan Medical CenterDaegu, South KoreaTaking people
- Chungnam National University HospitalDaejeon, South KoreaTaking people
- Gangneung Asan HospitalGangneung, South KoreaNo longer taking part
- Chonnam National University HospitalGwangju, South KoreaTaking people
- Wonkwang University HospitalIksan, South KoreaNo longer taking part
- Inje University Ilsan Paik HospitalIlsan, South KoreaTaking people
- Gachon University Gil Medical CenterIncheon, South KoreaTaking people
- Chonbuk National University HospitalJeonju, South KoreaTaking people
- Chungnam National University Sejong HospitalSejong, South KoreaTaking people
- Seoul university Bundang hospitalSeongnam, South KoreaTaking people
- Asan Medical CenterSeoul, South KoreaTaking people
- Ewha Womans University Mokdong HospitalSeoul, South KoreaTaking people
- Kangdong KyungHee University hospitalSeoul, South KoreaTaking people
- Korea University Anam HospitalSeoul, South KoreaTaking people
- Seoul National University Boramae Medical CenterSeoul, South KoreaTaking people
- Seoul National University HospitalSeoul, South KoreaTaking people
- Korea University Guro HospitalSeoul, South KoreaNo longer taking part
- Severance hospitalSeoul, South KoreaNo longer taking part
- The Catholic Univ. of Korea Seoul St. Mary's HospitalSeoul, South KoreaNo longer taking part
- The Catholic University of Korea, Eunpyeong St. Mary's HospitalSeoul, South KoreaNo longer taking part
- Ajou University HospitalSuwon, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kee-joon Choi
- Trial code
- NCT02845531
- Record updated
- 25 June 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; Prior pacemaker or Implantable Cardioverter Defibrillator; Chronic Heart Failure New York Heart Association functional class III or IV; Psychiatric illnesses that may be aggravated by device implantation or that may preclude systematic follow-up; 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; Primary cardiac electrical diseases (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia); Life expectancy <2 years; Significant (>50%) coronary artery stenosis on coronary angiography; 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).