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

Study Overview
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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%.

Official Title
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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

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

Intervention / Treatment
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* Device: Implantable cardioverter defibrillator


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, parallel-group, open-label, superiority trial with two arms with 1:1 randomization through an internet-based randomization module.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Revascularization, Percutaneous coronary intervention, Implantable cardioverter defibrillator