Angina Pectoris, Variant, Sudden Cardiac Death
Conditions
Keywords
Variant angina, Aborted sudden cardiac death, Implantable Cardioverter Defibrillator, Optimal Medical Therapy, ICD
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.
Interventions
DEVICEImplantable Cardioverter Defibrillator
Implantable Cardioverter Defibrillator and Optimal Medical Therapy
DRUGOptimal Medical Therapy
Sponsors
Kee-joon Choi
CardioVascular Research Foundation, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death from any cause | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event rate of Cardiac death | 5 years | — |
| Event rate of Death from arrhythmia | 5 years | — |
| Event rate of Cardiac arrest | 5 years | — |
| Event rate of Recurrence of ventricular tachyarrhythmia | 5 years | — |
| Event rate of Hospitalization | 5 years | Hospitalization due to unstable angina, acute myocardial infarction, heart failure, cardiac arrhythmia |
| 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 Inappropriate ICD therapies | 5 years | — |
| Event rate of Major device-related complications | 5 years | — |
| Event rate of Stroke | 5 years | — |
Countries
South Korea
Contacts
CONTACTKee-joon Choi, MD
Outcome results
None listed