Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implantable Cardioverter Defibrillator, Optimal Medical Therapy.
- Who it may be relevant to
- Registry conditions: Angina Pectoris, Variant, Sudden Cardiac Death. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device Implantable Cardioverter Defibrillator
Implantable Cardioverter Defibrillator and Optimal Medical Therapy - Drug Optimal Medical Therapy
Primary outcome measures
- Death from any cause [Time frame: 5 years]
Secondary outcome measures (9)
- 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]
- Event rate of Appropriate ICD therapies [Time frame: 5 years]
- Event rate of Inappropriate ICD therapies [Time frame: 5 years]
- Event rate of Major device-related complications [Time frame: 5 years]
- Event rate of Stroke [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 26 centers
- Soon Chun Hyang University Hospital Bucheon — Bucheon-si
- Busan National University Yangsan Hospital — Busan
- Busan University Hospital — Busan
- Dong-A Medical Center — Busan
- Soon Chun Hyang University Hospital Cheonan — Cheonan
- Keimyung University Dongsan Medical Center — Daegu
- Chungnam National University Hospital — Daejeon
- Gangneung Asan Hospital — Gangneung
- … and 18 more centers
Identifiers
NCT: NCT02845531 · AMCCV2016-15