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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Soon Chun Hyang University Hospital Bucheon
  Bucheon-si, South Korea Recruiting
• Busan National University Yangsan Hospital
  Busan, South Korea Recruiting
• Dong-A Medical Center
  Busan, South Korea Recruiting
• Keimyung University Dongsan Medical Center
  Daegu, South Korea Recruiting
• Chungnam National University Hospital
  Daejeon, South Korea Recruiting
• Chonnam National University Hospital
  Gwangju, South Korea Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.