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

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.

Study Overview

• Status: Recruiting
• Conditions: Angina Pectoris, Variant; Sudden Cardiac Death
• Intervention / Treatment: Device: Implantable Cardioverter Defibrillator; Drug: Optimal Medical Therapy

Detailed Description

All participants will be monitored over a span of five years and the time point of the year of last subject last visit. The term "year of last subject last visit" refers to the time point of the last visit for all participants. At this specific time point, event occurrence check will be conducted to determine the occurrence of endpoint events among all participants.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kee-joon Choi, MD; Email: kjchoi@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Recruiting
    • Soon Chun Hyang University Hospital Bucheon
    • Contact: Hyung-o Choi, MD
    • Principal Investigator: Hyung-o Choi, MD
  • Busan, Korea, Republic of
    • Recruiting
    • Dong-A Medical Center
    • Principal Investigator: Jong-sung Park, MD
    • Contact: Jong-sung Park, MD
  • Busan, Korea, Republic of
    • Recruiting
    • Busan National University Yangsan Hospital
    • Principal Investigator: Ki-won Hwang, MD
    • Contact: Ki-won Hwang, MD
  • Busan, Korea, Republic of
    • Recruiting
    • Busan University Hospital
    • Principal Investigator: Jin-hee Ahn, MD
    • Contact: Jin-hee Ahn, MD
  • Cheonan, Korea, Republic of
    • Recruiting
    • Soon Chun Hyang University Hospital Cheonan
    • Contact: Ha-young Choi, MD
    • Principal Investigator: Ha-young Choi, MD
  • Daegu, Korea, Republic of
    • Recruiting
    • Keimyung University Dongsan Medical Center
    • Contact: Jongmin Hwang, MD
    • Principal Investigator: Jongmin Hwang, MD
  • Daejeon, Korea, Republic of
    • Recruiting
    • Chungnam national university hospital
    • Contact: Jae-hyung Park, MD
    • Principal Investigator: Jae-hyung Park, MD
  • Gangneung, Korea, Republic of
    • Withdrawn
    • GangNeung Asan Hospital
  • Gwangju, Korea, Republic of
    • Recruiting
    • Chonnam National University Hospital
    • Principal Investigator: Hyung-wook Park, MD
    • Contact: Hyung-wook Park, MD
  • Iksan, Korea, Republic of
    • Withdrawn
    • Wonkwang University Hospital
  • Incheon, Korea, Republic of
    • Recruiting
    • Gachon University Gil Medical Center
    • Principal Investigator: Seung-hwan Han, MD
    • Contact: Seung-Hwan Han, MDD
  • Jeonju, Korea, Republic of
    • Recruiting
    • Chonbuk National University Hospital
    • Principal Investigator: Kyung-seok Lee, MD
    • Contact: Kyung-seok Lee, MD
  • Sejong, Korea, Republic of
    • Recruiting
    • Chungnam National University Sejong Hospital
    • Contact: Minsu Kim, MD
    • Principal Investigator: Minsu Kim, MD
  • Seongnam, Korea, Republic of
    • Recruiting
    • Seoul university Bundang hospital
    • Contact: Il-young Oh, MD
    • Principal Investigator: Il-Young Oh, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Principal Investigator: Kee-joon Choi, MD
    • Contact: Kee-joon Choi, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Principal Investigator: Se-il Oh, MD
    • Contact: Se-il Oh, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Anam Hospital
    • Principal Investigator: Young-hoon Kim, MD
    • Contact: Young-hoon Kim, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Ewha Womans University Mokdong Hospital
    • Principal Investigator: Jun-Beom Park, MD
    • Contact: Jun-Beom Park, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Boramae Medical Center
    • Principal Investigator: Woo-hyun Lim, MD
    • Contact: Woo-hyun Lim, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Kangdong KyungHee University Hospital
    • Principal Investigator: Eun-sun Jin, MD
    • Contact: Eun-sun Jin, MD
  • Seoul, Korea, Republic of
    • Terminated
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • The Catholic Univ. of Korea, Seoul St. Mary'S Hospital
    • Contact: Kiyuk Chang, MD
    • Principal Investigator: Kiyuk Chang, MD
  • Seoul, Korea, Republic of
    • Withdrawn
    • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Withdrawn
    • Severance Hospital
  • Suwon, Korea, Republic of
    • Active, not recruiting
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICD implantation and optimal medical therapy	Device: Implantable Cardioverter Defibrillator; Implantable Cardioverter Defibrillator and Optimal Medical Therapy
Active Comparator: optimal medical therapy	Drug: Optimal Medical Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Death from any cause	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Hospitalization due to unstable angina, acute myocardial infarction, heart failure, cardiac arrhythmia	5 years
Event rate of Appropriate ICD therapies	Appropriate ICD therapies defined as device-administered antitachycardia or defibrillation treatment for ventricular tachyarrhythmia that had not terminated spontaneously	5 years
Event rate of Inappropriate ICD therapies		5 years
Event rate of Major device-related complications		5 years
Event rate of Stroke		5 years

Collaborators and Investigators

• Sponsor: Kee-joon Choi
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2016
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: July 24, 2016
• First Submitted That Met QC Criteria: July 24, 2016
• First Posted (Estimated): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: ICD; Implantable Cardioverter Defibrillator; Variant angina; Aborted sudden cardiac death; Optimal Medical Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Myocardial Ischemia; Heart Arrest; Death, Sudden; Chest Pain; Angina, Unstable; Death, Sudden, Cardiac; Death; Angina Pectoris; Angina Pectoris, Variant
• Other Study ID Numbers: AMCCV2016-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No