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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Recruiting

CT.gov ID

NCT04576130

Collaborator

(none)

1,200

Enrollment

Location

Arms

143.6

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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%.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Acute Myocardial Infarction Ventricular Fibrillation Ventricular Tachycardia, Sustained Out-Of-Hospital Cardiac Arrest	Device: Implantable cardioverter defibrillator	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Masking Description:

Treatment cannot be blinded, we will use several endpoints that do not require an endpoint committee evaluation.

Primary Purpose:

Prevention

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

Actual Study Start Date :

Oct 12, 2020

Anticipated Primary Completion Date :

Oct 1, 2032

Anticipated Study Completion Date :

Oct 1, 2032

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Device revision or replacement due to infection or malfunction [1 year]
Explorative outcome
Appropriate shock from an ICD (successfully treated VT/VF) [1 year]
Explorative outcome
Inappropriate shock from an ICD (shock on non-VT/VF) [1 year]
Explorative outcome
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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