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

Not Applicable

Recruiting

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0002945
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1Age 18 years or older
2Patients experienced successfully resuscitated cardiac arrest due to documented ventricular fibrillation or sustained rapid ventricular tachycardia within 6 months of randomization
3Normal on coronary angiogram as no evidence of =50% stenosis or ischemic lesion and diagnosed as variant angina which is defined by spontaneous coronary spasm with ST elevation (=0.1mV) or =90% of lumen loss in the coronary angiogram on ergonovine provocation coronary angiography
4Patent or legal representative agrees to the trial protocol and follow-up surveillence and provides written informed consent on IRB/EC approved template

Exclusion Criteria

1Significant (>50%) coronary artery stenosis on coronary angiography
2Organic heart disease known to be associated with sudden cardiac arrest.
-          Heart failure with reduced ejection fraction (LV EF < 35%)
-          Presence of LV akinesia or aneurysm
-          Hypertrophic cardiomyopathy
-          Arrhythmogenic right ventricular dysplasia
3CHF New York Heart Association functional class III or IV
4prior history of atrial or ventricular arrhythmia requiring class I or III antiarrhythmic drugs (flecainide, propafenone, amiodarone, sotalol and dronedarone)
5Primary cardiac electrical diseases (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia)
6Prior pacemaker or Implantable Cardioverter Defibrillator (ICD)
72nd or 3rd degree AV block not related to coronary ischemia, requiring permanent pacemaker
8Patients with poor neurologic outcome (defined as cerebral performance category scale =3)
9Significant abnormalities on physical examination, blood test, ecg on screening visit and at the discretion of investigator
10Likely to not be available to adhere to protocol procedure
11Pregnant, breast feeding or in childbearing age
12Life expectancy =2years

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified