KCT0002945
Recruiting
N/A
Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
ConditionsDiseases of the circulatory system
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diseases of the circulatory system
- Sponsor
- Asan Medical Center
- Enrollment
- 140
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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