Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
VARIANT ICD
1 other identifier
interventional
140
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2016
Longer than P75 for phase_4
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2016
CompletedFirst Posted
Study publicly available on registry
July 27, 2016
CompletedStudy Start
First participant enrolled
November 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2031
June 15, 2025
June 1, 2025
14 years
July 24, 2016
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death from any cause
5 years
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (2)
ICD implantation and optimal medical therapy
EXPERIMENTALoptimal medical therapy
ACTIVE COMPARATORInterventions
Implantable Cardioverter Defibrillator and Optimal Medical Therapy
Eligibility Criteria
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
- nd 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kee-joon Choilead
- CardioVascular Research Foundation, Koreacollaborator
Study Sites (25)
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
Busan National University Yangsan Hospital
Busan, South Korea
Busan University Hospital
Busan, South Korea
Dong-A Medical Center
Busan, South Korea
Soon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Wonkwang University Hospital
Iksan, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Chungnam National University Sejong Hospital
Sejong, South Korea
Seoul university Bundang hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Kangdong KyungHee University hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
The Catholic Univ. of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor of medicine
Study Record Dates
First Submitted
July 24, 2016
First Posted
July 27, 2016
Study Start
November 29, 2016
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
June 1, 2031
Last Updated
June 15, 2025
Record last verified: 2025-06