Clinical Trial: Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title:
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 Summary:
Sponsor: Kee-joon Choi
Current Primary Outcome: Death from any cause [ Time Frame: 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Event rate of Cardiac death [ Time Frame: 5 years ]
- Event rate of Death from arrhythmia [ Time Frame: 5 years ]
- Event rate of Cardiac arrest [ Time Frame: 5 years ]
- Event rate of Recurrence of ventricular tachyarrhythmia [ Time Frame: 5 years ]
- Event rate of Hospitalization [ Time Frame: 5 years ]Hospitalization due to unstable angina, acute myocardial infarction, heart failure, cardiac arrhythmia
- Event rate of Appropriate ICD therapies [ Time Frame: 5 years ]Appropriate ICD therapies defined as device-administered antitachycardia or defibrillation treatment for ventricular tachyarrhythmia that had not terminated spontaneously
- Event rate of Inappropriate ICD therapies [ Time Frame: 5 years ]
- Event rate of Major device-related complications [ Time Frame: 5 years ]
Original Secondary Outcome: Same as current
Information By: Asan Medical Center
Dates:
Date Received: July 24, 2016
Date Started: November 29, 2016
Date Completion: June 2023
Last Updated: January 19, 2017
Last Verified: January 2017
