Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02845531
Other study ID # AMCCV2016-15
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date November 29, 2016
Est. completion date June 2030

Study information

Verified date February 2024
Source Asan Medical Center
Contact Kee-joon Choi, MD
Email kjchoi@amc.seoul.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 140
Est. completion date June 2030
Est. primary completion date December 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Implantable Cardioverter Defibrillator
Implantable Cardioverter Defibrillator and Optimal Medical Therapy
Drug:
Optimal Medical Therapy


Locations

Country Name City State
Korea, Republic of Soon Chun Hyang University Hospital Bucheon Bucheon
Korea, Republic of Busan National University Yangsan Hospital Busan
Korea, Republic of Busan University Hospital Busan
Korea, Republic of Dong-A Medical Center Busan
Korea, Republic of Soon Chun Hyang University Hospital Cheonan Cheonan
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
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 Wonkwang University Hospital Iksan
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of Chonbuk National University Hospital Jeonju
Korea, Republic of Chungnam National University Sejong Hospital Sejong
Korea, Republic of Seoul university Bundang hospital Seongnam
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Ewha Womans University Mokdong Hospital 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 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 The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul
Korea, Republic of Ajou University Hospital Suwon

Sponsors (2)

Lead Sponsor Collaborator
Kee-joon Choi CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Death from any cause 5 years
Secondary Event rate of Cardiac death 5 years
Secondary Event rate of Death from arrhythmia 5 years
Secondary Event rate of Cardiac arrest 5 years
Secondary Event rate of Recurrence of ventricular tachyarrhythmia 5 years
Secondary Event rate of Hospitalization Hospitalization due to unstable angina, acute myocardial infarction, heart failure, cardiac arrhythmia 5 years
Secondary 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
Secondary Event rate of Inappropriate ICD therapies 5 years
Secondary Event rate of Major device-related complications 5 years
Secondary Event rate of Stroke 5 years
See also
  Status Clinical Trial Phase
Completed NCT02923726 - Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP N/A
Recruiting NCT05175937 - REal World Assessment for Patients Implanted With Implantable CardioverTer DefibrIllatOr Using Bluetooth Technology
Completed NCT02026102 - A Pilot Trial of Patient Decision Aids for Implantable Cardioverter-Defibrillators (ICDs) N/A
Completed NCT01262508 - Development of Algorithms to Predict Hemodynamic Instability N/A
Completed NCT00998218 - Effect of Ranolazine on Arrhythmias and Microvolt T- Wave Alternans (MVTWA) Patients With LV Dysfunction Phase 3
Completed NCT00845286 - Marathon, Genetics, Inflammation and the Cardiovascular System: MAGIC-Trial N/A
Active, not recruiting NCT00562757 - Prospective Study to Identify Patients at Risk of Dangerous Ventricular Arrhythmias N/A
Completed NCT00622453 - Arrhythmias in Myotonic Muscular Dystrophy N/A
Completed NCT03833843 - Sudden Cardiac Death in Systemic Right Ventricle
Completed NCT04024865 - Domperidone and Risk of Serious Cardiac Events in Postpartum Women
Recruiting NCT05799833 - Low QRS Voltages in Young Healthy Individuals and Athletes
Recruiting NCT05694572 - Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
Not yet recruiting NCT03622307 - Subcutaneous ICD Therapy Combined With VT Ablation for the Secondary Prevention of Sudden Cardiac Death N/A
Recruiting NCT02058771 - Utilising Lifemap to Investigate Malignant Arrhythmia Therapy
Recruiting NCT02056509 - The Effect of Chest Compression and Ventilation Coordination During Cardiopulmonary Resuscitation. N/A
Terminated NCT01948206 - Study of Paced QRS Duration as a Marker of Sudden Cardiac Death N/A
Completed NCT01227785 - Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study N/A
Completed NCT00534300 - Intravenous n-3 Fatty Acids and Ventricular Tachycardia in Patients With Implantable Cardioverter Defibrillator (ICD)-Pacemaker Phase 1/Phase 2
Terminated NCT00524862 - Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death N/A
Recruiting NCT00181233 - Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk