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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-12

Study Completion Date

2032-10-31

Brief Summary

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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%.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

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

Study Groups

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ICD-implantation

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

Group Type EXPERIMENTAL

Implantable cardioverter defibrillator

Intervention Type DEVICE

Implantation of an ICD for secondary prevention

Standard care

Guideline directed medical therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Implantable cardioverter defibrillator

Implantation of an ICD for secondary prevention

Intervention Type DEVICE

Other Intervention Names

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ICD

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No