NCT02845531RecruitingPhase 4
Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 24 Jul 2016
- Start date
- 29 Nov 2016
- Primary completion date
- Dec 2030
- Lead sponsor
- Kee-joon Choi
- Diseases
- Coronary artery disease
- NCT number
- NCT02845531
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 140
- From 29 Nov 2016 to the primary completion date, Dec 2030
- 26 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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)
Age
- Life expectancy \<2 years
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Soon Chun Hyang University Hospital Bucheon Coordinator of this site? Confirm its status | Bucheon-si | South Korea | Recruiting |
| Busan University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Active, not recruiting |
| Dong-A Medical Center Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Busan National University Yangsan Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Soon Chun Hyang University Hospital Cheonan Coordinator of this site? Confirm its status | Cheonan | South Korea | Active, not recruiting |
| Keimyung University - Dongsan Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Recruiting |
| Gangneung Asan Hospital Coordinator of this site? Confirm its status | Gangneung | South Korea | Withdrawn |
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Recruiting |
| Wonkwang University Hospital Coordinator of this site? Confirm its status | Iksan | South Korea | Withdrawn |
| Inje University Ilsan Paik Hospital Coordinator of this site? Confirm its status | Ilsan | South Korea | Recruiting |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Chonbuk National University Hospital Coordinator of this site? Confirm its status | Jeonju | South Korea | Recruiting |
| Chungnam National University Sejong Hospital Coordinator of this site? Confirm its status | Sejong | South Korea | Recruiting |
| Seoul university Bundang hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Recruiting |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Terminated |
| Seoul National University Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Kangdong KyungHee University hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Withdrawn |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Active, not recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Ewha Womans University Mokdong Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Withdrawn |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.