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

Not Applicable

Recruiting

• Conditions: Ventricular Tachycardia, Sustained; Acute Myocardial Infarction; Coronary Artery Disease; Ventricular Fibrillation; Out-Of-Hospital Cardiac Arrest
• Interventions: Device: Implantable cardioverter defibrillator

• Registration Number: NCT04576130
• Lead Sponsor: Rigshospitalet, Denmark

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%.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-06
• Study Start: 2020-10-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Primary Completion: 2032-10
• Study Completion: 2032-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICD-implantation	Implantable cardioverter defibrillator	Implantation of an ICD either during admission or within 4 weeks after discharge from index event.

Primary Outcome Measures

Name	Time	Method
All-cause mortality	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.

Secondary Outcome Measures

Name	Time	Method
All cause mortality	1 year
Sudden cardiovascular death	1 year	Cardiovascular death fulfilling the following criteria: * In witnessed cases a change in cardiovascular status with time until death being \<1 hour.; * In unwitnessed cases \<24 hours since last seen alive and functioning normal.
Cardiovascular death	1 year	Mortality is considered as cardiovascular unless it is clearly attributable to another cause and thus includes: * Death due to proximate cardiac cause (e.g. myocardial infarction, cardiac tamponade, worsening heart failure).; * Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease.; * All procedure-related deaths, including those related to a complication of the ICD-procedure or treatment for a complication of the procedure.; * All valve-related deaths including structural or non-structural valve dysfunction or other valve-related adverse events.; * Death of unknown or cardiac cause.

Trial Locations

Locations (1)

Copenhagen University Hospital, Rigshospitalet; 🇩🇰 Copenhagen, Denmark