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

NCT04576130 | Recruiting DMC FDA Device

• 1 other identifier: H-20007332
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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%.

Conditions

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

Keywords

Revascularization; Percutaneous coronary intervention; Implantable cardioverter defibrillator

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• All cause mortality

  1 year

• Sudden cardiovascular death

  1 year

• Cardiovascular death

  1 year

Other Outcomes (8)

• Device revision or replacement due to infection or malfunction

  1 year

• Appropriate shock from an ICD (successfully treated VT/VF)

  1 year

• Inappropriate shock from an ICD (shock on non-VT/VF)

  1 year

Study Arms (2)

ICD-implantation

EXPERIMENTAL

Implantation of an ICD either during admission or within 4 weeks after discharge from index event.

Device: Implantable cardioverter defibrillator

Standard care

NO INTERVENTION

Guideline directed medical therapy

Interventions

Implantable cardioverter defibrillator DEVICE

Implantation of an ICD for secondary prevention

Also known as: ICD

ICD-implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Ventricular Fibrillation; Tachycardia, Ventricular; Out-of-Hospital Cardiac Arrest

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease; Heart Arrest

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Reza Jabbari, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reza Jabbari, MD, PhD

CONTACT

+4535455380; reza.jabbari.02@regionh.dk

Thomas Engstrøm, MD, PhD, DMSc

CONTACT

+4535458444; thomas.engstroem@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Treatment cannot be blinded, we will use several endpoints that do not require an endpoint committee evaluation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, PhD

Model Details: Randomized, parallel-group, open-label, superiority trial with two arms with 1:1 randomization through an internet-based randomization module.

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 6, 2020
• Study Start: October 12, 2020
• Primary Completion (Estimated): October 1, 2032
• Study Completion (Estimated): October 1, 2032
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

DK (1)