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

February 21, 2024 updated by: Kee-joon Choi
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Recruiting
        • Soon Chun Hyang University Hospital Bucheon
        • Contact:
          • Hyun-woo Park, MD
        • Principal Investigator:
          • Hyun-woo Park, MD
      • Busan, Korea, Republic of
        • Recruiting
        • Dong-A Medical Center
        • Contact:
        • Principal Investigator:
          • Jong-sung Park, MD
      • Busan, Korea, Republic of
        • Recruiting
        • Busan National University Yangsan Hospital
        • Contact:
        • Principal Investigator:
          • Ki-won Hwang, MD
      • Busan, Korea, Republic of
        • Recruiting
        • Busan University Hospital
        • Contact:
        • Principal Investigator:
          • Jin-hee Ahn, MD
      • Cheonan, Korea, Republic of
        • Recruiting
        • Soon Chun Hyang University Hospital Cheonan
        • Contact:
        • Principal Investigator:
          • Se-whan Lee, MD
      • Daegu, Korea, Republic of
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
        • Principal Investigator:
          • Sung-wook Han, 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
        • Contact:
        • Principal Investigator:
          • Hyung-wook Park, MD
      • Iksan, Korea, Republic of
        • Withdrawn
        • Wonkwang University Hospital
      • Incheon, Korea, Republic of
        • Recruiting
        • Gachon University Gil Medical Center
        • Contact:
        • Principal Investigator:
          • Seung-Hwan Han, MD
      • Jeonju, Korea, Republic of
        • Recruiting
        • Chonbuk National University Hospital
        • Contact:
        • Principal Investigator:
          • Kyung-seok Lee, MD
      • Sejong, Korea, Republic of
        • Not yet recruiting
        • Chungnam National University Sejong Hospital
        • Contact:
          • Jae-whan Lee, MD
        • Principal Investigator:
          • Jae-whan Lee, 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
        • Contact:
        • Principal Investigator:
          • Kee-joon Choi, MD
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Se-il Oh, MD
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
        • Principal Investigator:
          • Young-hoon Kim, MD
      • Seoul, Korea, Republic of
        • Recruiting
        • Ewha Womans University Mokdong Hospital
        • Contact:
        • Principal Investigator:
          • Jun-Beom Park, MD
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Boramae Medical Center
        • Contact:
        • Principal Investigator:
          • Woo-hyun Lim, MD
      • Seoul, Korea, Republic of
        • Active, not recruiting
        • Severance Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Kangdong KyungHee University hospital
        • Contact:
        • Principal Investigator:
          • 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:
        • Principal Investigator:
          • Sung-hwan Kim, MD
      • Seoul, Korea, Republic of
        • Withdrawn
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
      • Suwon, Korea, Republic of
        • Active, not recruiting
        • Ajou University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event rate of Cardiac death
Time Frame: 5 years
5 years
Event rate of Death from arrhythmia
Time Frame: 5 years
5 years
Event rate of Cardiac arrest
Time Frame: 5 years
5 years
Event rate of Recurrence of ventricular tachyarrhythmia
Time Frame: 5 years
5 years
Event rate of Hospitalization
Time Frame: 5 years
Hospitalization due to unstable angina, acute myocardial infarction, heart failure, cardiac arrhythmia
5 years
Event rate of Appropriate ICD therapies
Time Frame: 5 years
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
Time Frame: 5 years
5 years
Event rate of Major device-related complications
Time Frame: 5 years
5 years
Event rate of Stroke
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kee-joon Choi

Collaborators

CardioVascular Research Foundation, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2016

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

June 1, 2030

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 (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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