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

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

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%.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reza Jabbari, MD, PhD; Phone Number: +4535455380; Email: reza.jabbari.02@regionh.dk
• Study Contact Backup: Name: Thomas Engstrøm, MD, PhD, DMSc; Phone Number: +4535458444; Email: thomas.engstroem@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Copenhagen University Hospital, Rigshospitalet
    • Contact: Reza Jabbari, MD, PhD; Phone Number: +4535455380; Email: reza.jabbari.02@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICD-implantation; Implantation of an ICD either during admission or within 4 weeks after discharge from index event.	Device: Implantable cardioverter defibrillator; Implantation of an ICD for secondary prevention; Other Names: ICD
No Intervention: Standard care; Guideline directed medical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality		1 year
Sudden cardiovascular death	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.	1 year
Cardiovascular death	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.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device revision or replacement due to infection or malfunction	Explorative outcome	1 year
Appropriate shock from an ICD (successfully treated VT/VF)	Explorative outcome	1 year
Inappropriate shock from an ICD (shock on non-VT/VF)	Explorative outcome	1 year
Register-based all cause mortality		10 years
Register-based sudden cardiovascular death		5 years
Register-based sudden cardiovascular death		10 years
Register-based cardiovascular death		5 years
Register-based cardiovascular death		10 years

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Reza Jabbari, MD, PhD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2020
• Primary Completion (Estimated): October 1, 2032
• Study Completion (Estimated): October 1, 2032

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Revascularization; Percutaneous coronary intervention; Implantable cardioverter defibrillator
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Infarction; Heart Arrest; Myocardial Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: H-20007332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes