Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
- Conditions
- Angina Pectoris, VariantSudden Cardiac Death
- Interventions
- Drug: Optimal Medical TherapyDevice: Implantable Cardioverter Defibrillator
- Registration Number
- NCT02845531
- Lead Sponsor
- Kee-joon Choi
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 140
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description optimal medical therapy Optimal Medical Therapy - ICD implantation and optimal medical therapy Implantable Cardioverter Defibrillator -
- Primary Outcome Measures
Name Time Method Death from any cause 5 years
- Secondary Outcome Measures
Name Time Method Event rate of Cardiac death 5 years Event rate of Hospitalization 5 years Hospitalization due to unstable angina, acute myocardial infarction, heart failure, cardiac arrhythmia
Event rate of Inappropriate ICD therapies 5 years Event rate of Major device-related complications 5 years Event rate of Recurrence of ventricular tachyarrhythmia 5 years Event rate of Death from arrhythmia 5 years Event rate of Cardiac arrest 5 years Event rate of Appropriate ICD therapies 5 years Appropriate ICD therapies defined as device-administered antitachycardia or defibrillation treatment for ventricular tachyarrhythmia that had not terminated spontaneously
Event rate of Stroke 5 years
Trial Locations
- Locations (25)
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Korea, Republic of
Busan National University Yangsan Hospital
🇰🇷Busan, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Busan University Hospital
🇰🇷Busan, Korea, Republic of
Dong-A Medical Center
🇰🇷Busan, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Chungnam National University Sejong Hospital
🇰🇷Sejong, Korea, Republic of
Seoul university Bundang hospital
🇰🇷Seongnam, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic Univ. of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Kangdong KyungHee University hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of