Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT02845531

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

Led by Kee-joon Choi · Updated on 2025-06-15

140

Participants Needed

25

Research Sites

756 weeks

Total Duration

On this page

Sponsors

K

Kee-joon Choi

Lead Sponsor

C

CardioVascular Research Foundation, Korea

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Patients who had a successfully resuscitated cardiac arrest due to documented ventricular fibrillation or sustained rapid ventricular tachycardia
  • Diagnosed with variant angina confirmed by spontaneous coronary spasm with ST elevation (≥0.1mV) in coronary angiogram and/or documented coronary spasm on ergonovine provocation coronary angiography
Not Eligible

You will not qualify if you...

  • Significant coronary artery stenosis greater than 50% on coronary angiography
  • Known organic heart disease linked to sudden cardiac arrest, including heart failure with left ventricular ejection fraction below 35%, left ventricular akinesia or aneurysm, hypertrophic cardiomyopathy, and arrhythmogenic right ventricular dysplasia
  • Chronic heart failure classified as 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, dronedarone)
  • Previous catheter ablation for ventricular arrhythmia
  • Primary cardiac electrical diseases like long QT syndrome, Brugada syndrome, or catecholaminergic polymorphic ventricular tachycardia
  • Previous pacemaker or Implantable Cardioverter Defibrillator
  • Second or third degree AV block not related to coronary ischemia requiring a permanent pacemaker
  • Poor neurologic outcome defined as cerebral performance category scale 3 or higher
  • Life expectancy less than 2 years
  • Psychiatric illnesses that could worsen with device implantation or prevent follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 25 locations

1

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

Actively Recruiting

2

Busan National University Yangsan Hospital

Busan, South Korea

Actively Recruiting

3

Busan University Hospital

Busan, South Korea

Actively Recruiting

4

Dong-A Medical Center

Busan, South Korea

Actively Recruiting

5

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

Actively Recruiting

6

Keimyung University Dongsan Medical Center

Daegu, South Korea

Actively Recruiting

7

Chungnam National University Hospital

Daejeon, South Korea

Actively Recruiting

8

Gangneung Asan Hospital

Gangneung, South Korea

Withdrawn

9

Chonnam National University Hospital

Gwangju, South Korea

Actively Recruiting

10

Wonkwang University Hospital

Iksan, South Korea

Withdrawn

11

Gachon University Gil Medical Center

Incheon, South Korea

Actively Recruiting

12

Chonbuk National University Hospital

Jeonju, South Korea

Actively Recruiting

13

Chungnam National University Sejong Hospital

Sejong, South Korea

Actively Recruiting

14

Seoul university Bundang hospital

Seongnam, South Korea

Actively Recruiting

15

Asan Medical Center

Seoul, South Korea

Actively Recruiting

16

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Actively Recruiting

17

Kangdong KyungHee University hospital

Seoul, South Korea

Actively Recruiting

18

Korea University Anam Hospital

Seoul, South Korea

Actively Recruiting

19

Korea University Guro Hospital

Seoul, South Korea

Terminated

20

Seoul National University Boramae Medical Center

Seoul, South Korea

Actively Recruiting

21

Seoul National University Hospital

Seoul, South Korea

Actively Recruiting

22

Severance Hospital

Seoul, South Korea

Withdrawn

23

The Catholic Univ. of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Actively Recruiting

24

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, South Korea

Withdrawn

25

Ajou University Hospital

Suwon, South Korea

Active, Not Recruiting

Loading map...

Research Team

K

Kee-joon Choi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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