Comparing Implantable Defibrillators and Medical Therapy for Variant Angina and Sudden Cardiac Death

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

This study tests if adding an implantable defibrillator to standard treatment can help people with variant angina who have survived sudden cardiac death live longer.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Asan Medical Center (Academic / other)
• Locations: 25 sites (Bucheon-si and 24 other locations)
• Trial ID: NCT02845531 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of implantable cardioverter defibrillator (ICD) implantation combined with optimal medical therapy in patients who have variant angina and have experienced aborted sudden cardiac death. Participants will be monitored over five years to assess the incidence of death from any cause compared to those receiving only optimal medical therapy. The study focuses on patients who have documented ventricular fibrillation or sustained rapid ventricular tachycardia due to variant angina. The goal is to determine if the addition of ICD can significantly reduce mortality rates in this high-risk population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have experienced successfully resuscitated cardiac arrest due to documented ventricular fibrillation or sustained rapid ventricular tachycardia and have a diagnosis of variant angina.

Not a fit: Patients with significant coronary artery stenosis or other organic heart diseases associated with sudden cardiac arrest may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce mortality rates in patients with variant angina and a history of sudden cardiac arrest.

How similar studies have performed: Previous studies have shown promising results with ICDs in similar high-risk cardiac populations, suggesting potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Bucheon-si and 24 other locations

• Soon Chun Hyang University Hospital Bucheon — Bucheon-si, South Korea (Recruiting)
• Busan National University Yangsan Hospital — Busan, South Korea (Recruiting)
• Busan University Hospital — Busan, South Korea (Recruiting)
• Dong-A Medical Center — Busan, South Korea (Recruiting)
• Soon Chun Hyang University Hospital Cheonan — Cheonan, South Korea (Recruiting)
• Keimyung University Dongsan Medical Center — Daegu, South Korea (Recruiting)
• Chungnam National University Hospital — Daejeon, South Korea (Recruiting)
• Gangneung Asan Hospital — Gangneung, South Korea (Withdrawn)
• Chonnam National University Hospital — Gwangju, South Korea (Recruiting)
• Wonkwang University Hospital — Iksan, South Korea (Withdrawn)
• Gachon University Gil Medical Center — Incheon, South Korea (Recruiting)
• Chonbuk National University Hospital — Jeonju, South Korea (Recruiting)
• Chungnam National University Sejong Hospital — Sejong, South Korea (Recruiting)
• Seoul university Bundang hospital — Seongnam, South Korea (Recruiting)
• Asan Medical Center — Seoul, South Korea (Recruiting)
• Ewha Womans University Mokdong Hospital — Seoul, South Korea (Recruiting)
• Kangdong KyungHee University hospital — Seoul, South Korea (Recruiting)
• Korea University Anam Hospital — Seoul, South Korea (Recruiting)
• Korea University Guro Hospital — Seoul, South Korea (Terminated)
• Seoul National University Boramae Medical Center — Seoul, South Korea (Recruiting)
• Seoul National University Hospital — Seoul, South Korea (Recruiting)
• Severance Hospital — Seoul, South Korea (Withdrawn)
• The Catholic Univ. of Korea, Seoul St. Mary's Hospital — Seoul, South Korea (Recruiting)
• The Catholic University of Korea, Eunpyeong St. Mary's Hospital — Seoul, South Korea (Withdrawn)
• Ajou University Hospital — Suwon, South Korea (Active_not_recruiting)

Study contacts

• Study coordinator: Kee-joon Choi, MD

Conditions Angina Pectoris, Variant; Sudden Cardiac Death; Variant angina; Aborted sudden cardiac death; Implantable Cardioverter Defibrillator; Optimal Medical Therapy; ICD