Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-29

Study Completion Date

2031-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Angina Pectoris, Variant Sudden Cardiac Death

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICD implantation and optimal medical therapy

Group Type EXPERIMENTAL

Implantable Cardioverter Defibrillator

Intervention Type DEVICE

Implantable Cardioverter Defibrillator and Optimal Medical Therapy

optimal medical therapy

Group Type ACTIVE_COMPARATOR

Optimal Medical Therapy

Intervention Type DRUG

Interventions

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Implantable Cardioverter Defibrillator

Implantable Cardioverter Defibrillator and Optimal Medical Therapy

Intervention Type DEVICE

Optimal Medical Therapy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No