Clinical trial NCT04576130: A Danish ICD-study in Patients with Coronary Artery Disease Resuscitated from Ventricular Fibrillation
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel-group, open-label, superiority trial with two arms with 1:1 randomization through an internet-based randomization module.
Primary purpose: PREVENTION

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%.


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

Primary outcomes:
measure: All-cause mortality
timeFrame: 5 years
Secondary outcomes:
measure: All cause mortality
timeFrame: 1 year
measure: Sudden cardiovascular death
timeFrame: 1 year
measure: Cardiovascular death
timeFrame: 1 year
Other outcomes:
measure: Device revision or replacement due to infection or malfunction
timeFrame: 1 year
measure: Appropriate shock from an ICD (successfully treated VT/VF)
timeFrame: 1 year
measure: Inappropriate shock from an ICD (shock on non-VT/VF)
timeFrame: 1 year
measure: Register-based all cause mortality
timeFrame: 10 years
measure: Register-based sudden cardiovascular death
timeFrame: 5 years
measure: Register-based sudden cardiovascular death
timeFrame: 10 years
measure: Register-based cardiovascular death
timeFrame: 5 years
measure: Register-based cardiovascular death
timeFrame: 10 years
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Reza Jabbari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: