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

ConditionsAngina Pectoris, VariantSudden Cardiac Death
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorKee-joon Choi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Implantable Cardioverter Defibrillator

    Device

    Implantable Cardioverter Defibrillator and Optimal Medical Therapy

  • Optimal Medical Therapy

    Drug

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: ICD implantation and optimal medical therapyExperimental treatment 1 intervention
Group B: optimal medical therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Death from any cause

Time frame
5 years

Secondary outcomes

1

Event rate of Cardiac death

Time frame
5 years
2

Event rate of Death from arrhythmia

Time frame
5 years
3

Event rate of Cardiac arrest

Time frame
5 years
4

Event rate of Recurrence of ventricular tachyarrhythmia

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kee-joon Choi

Lead sponsor

Asan Medical Center

Sponsor institution

CardioVascular Research Foundation, Korea

Collaborator

Source ClinicalTrials.gov
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