A Danish ICD-study in Patients with Coronary Artery Disease Resuscitated from Ventricular Fibrillation (DanICD)

Rigshospitalet

Status

Enrolling

Conditions

Coronary Artery Disease

Ventricular Tachycardia, Sustained

Out-Of-Hospital Cardiac Arrest

Ventricular Fibrillation

Acute Myocardial Infarction

Treatments

Device: Implantable cardioverter defibrillator

Study type

Interventional

Funder types

Other

Identifiers

NCT04576130

H-20007332

Details and patient eligibility

About

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%.

Enrollment

1,200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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