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

Last updated: February 21, 2024
Sponsor: Kee-joon Choi
Overall Status: Active - Recruiting

Phase

4

Condition

Chest Pain

Circulation Disorders

Acute Pain

Treatment

Implantable Cardioverter Defibrillator

Optimal Medical Therapy

Clinical Study ID

NCT02845531
AMCCV2016-15
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years or older
  • Patients experienced successfully resuscitated cardiac arrest due to documentedventricular 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 ergonovineprovocation coronary angiography

Exclusion

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 IIIantiarrhythmic 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 permanentpacemaker
  • 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 maypreclude systematic follow-up

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Implantable Cardioverter Defibrillator
Phase: 4
Study Start date:
November 29, 2016
Estimated Completion Date:
June 30, 2030

Study 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.

Connect with a study center

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon,
    Korea, Republic of

    Active - Recruiting

  • Busan National University Yangsan Hospital

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Busan University Hospital

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Dong-A Medical Center

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Soon Chun Hyang University Hospital Cheonan

    Cheonan,
    Korea, Republic of

    Active - Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Chungnam National University Hospital

    Daejeon,
    Korea, Republic of

    Active - Recruiting

  • Gangneung Asan Hospital

    Gangneung,
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital

    Gwangju,
    Korea, Republic of

    Active - Recruiting

  • Wonkwang University Hospital

    Iksan,
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • Chonbuk National University Hospital

    Jeonju,
    Korea, Republic of

    Active - Recruiting

  • Chungnam National University Sejong Hospital

    Sejong,
    Korea, Republic of

    Site Not Available

  • Seoul university Bundang hospital

    Seongnam,
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Ewha Womans University Mokdong Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Kangdong KyungHee University hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Terminated

  • Seoul National University Boramae Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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

    Seoul,
    Korea, Republic of

    Active - Recruiting

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

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Site Not Available

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