A Danish Study to Assess the Efficacy of Implantable Cardioverter Defibrillator in Patients with Coronary Artery Disease Resuscitated from Ventricular Fibrillation Who Receive Complete Revascularization

Rigshospitalet, Denmark1 site in 1 country1,200 target enrollmentOctober 12, 2020

ConditionsCoronary Artery Disease Acute Myocardial Infarction Ventricular Fibrillation Ventricular Tachycardia, Sustained Out-Of-Hospital Cardiac Arrest

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Rigshospitalet, Denmark
Enrollment: 1200
Locations: 1
Primary Endpoint: All-cause mortality
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

DanICD is a randomized, controlled study to with the aim to assess whether there is a benefit of ICD-implantation in patients with coronary artery disease (including acute myocardial infarction), who survive cardiac arrest due to ventricular fibrillation/sustained ventricular tachycardia and undergo revascularization and with an LVEF above 35%.

Registry

clinicaltrials.gov

Start Date

October 12, 2020

End Date

October 2032

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rigshospitalet, Denmark

Responsible Party

Principal Investigator

Reza Jabbari

Principal investigator, MD, PhD

Rigshospitalet, Denmark

Eligibility Criteria

Inclusion Criteria

•Patients with CAD and cardiac arrest due to VF/VT, where angiogram is performed with complete revascularization (PCI, CABG or hybrid coronary revascularization) before ICD implantation. Unfavorable artery for PCI (i.e., excessive vessel tortuosity or chronic total occlusion) or high-risk invasive treatment is not mandatory in order to achive complete revascularization.
•Age ≥18 years
•LVEF \>35% at the time of discharge. The most recent LVEF assessment on which the current medical treatment will be based at the time of entry into the study will be used as baseline LVEF.

Exclusion Criteria

•Non-ischemic cause of cardiac arrest (i.e. ion channel diseases, non-ischemic cardiomyopathy)
•Previous CABG within the last 3 months before index hospitalization
•Life expectancy less than 1 year or severe neurologic outcome
•Unable or unwilling to give informed consent
•Pregnancy

Outcomes

Primary Outcomes

All-cause mortality

Time Frame: 5 years

The clinical event committee will aim to attribute the cause of death to the underlying disease process rather than the immediate mechanism. Mortality will be classified as cardiovascular and non-cardiovascular.