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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD implantation and optimal medical therapy | Experimental |
| |
| optimal medical therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Cardioverter Defibrillator | Device | Implantable Cardioverter Defibrillator and Optimal Medical Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death from any cause | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Event rate of Cardiac death | 5 years | |
| Event rate of Death from arrhythmia | 5 years | |
| Event rate of Cardiac arrest |
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Inclusion Criteria:
Exclusion Criteria:
Significant (>50%) coronary artery stenosis on coronary angiography
Organic heart disease known to be associated with sudden cardiac arrest.
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kee-joon Choi, MD | Contact | kjchoi@amc.seoul.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Hospital Bucheon | Recruiting | Bucheon-si | South Korea |
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| Optimal Medical Therapy | Drug |
|
| 5 years |
| Event rate of Recurrence of ventricular tachyarrhythmia | 5 years |
| Event rate of Hospitalization | Hospitalization due to unstable angina, acute myocardial infarction, heart failure, cardiac arrhythmia | 5 years |
| Event rate of Appropriate ICD therapies | Appropriate ICD therapies defined as device-administered antitachycardia or defibrillation treatment for ventricular tachyarrhythmia that had not terminated spontaneously | 5 years |
| Event rate of Inappropriate ICD therapies | 5 years |
| Event rate of Major device-related complications | 5 years |
| Event rate of Stroke | 5 years |
| Busan National University Yangsan Hospital | Recruiting | Busan | South Korea |
|
| Busan University Hospital | Active, not recruiting | Busan | South Korea |
| Dong-A Medical Center | Recruiting | Busan | South Korea |
|
| Soon Chun Hyang University Hospital Cheonan | Active, not recruiting | Cheonan | South Korea |
| Keimyung University Dongsan Medical Center | Recruiting | Daegu | South Korea |
|
| Chungnam National University Hospital | Recruiting | Daejeon | South Korea |
|
| Gangneung Asan Hospital | Withdrawn | Gangneung | South Korea |
| Chonnam National University Hospital | Recruiting | Gwangju | South Korea |
|
| Wonkwang University Hospital | Withdrawn | Iksan | South Korea |
| Inje University Ilsan Paik Hospital | Recruiting | Ilsan | South Korea |
|
| Gachon University Gil Medical Center | Recruiting | Incheon | South Korea |
|
| Chonbuk National University Hospital | Recruiting | Jeonju | South Korea |
|
| Chungnam National University Sejong Hospital | Recruiting | Sejong | South Korea |
|
| Seoul university Bundang hospital | Recruiting | Seongnam | South Korea |
|
| Asan Medical Center | Recruiting | Seoul | South Korea |
|
| Ewha Womans University Mokdong Hospital | Recruiting | Seoul | South Korea |
|
| Kangdong KyungHee University hospital | Recruiting | Seoul | South Korea |
|
| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
|
| Korea University Guro Hospital | Terminated | Seoul | South Korea |
| Seoul National University Boramae Medical Center | Recruiting | Seoul | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| Severance Hospital | Withdrawn | Seoul | South Korea |
| The Catholic Univ. of Korea, Seoul St. Mary's Hospital | Active, not recruiting | Seoul | South Korea |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital | Withdrawn | Seoul | South Korea |
| Ajou University Hospital | Recruiting | Suwon | South Korea |
|
| ID | Term |
|---|---|
| D000788 | Angina Pectoris, Variant |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D000789 | Angina, Unstable |
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D004567 | Electrodes, Implanted |
| D019736 | Prostheses and Implants |
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