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

Coronary Artery Disease Clinical Trial

— DanICD  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04576130
• Other study ID #: H-20007332
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: October 2032

Study information

• Verified date: November 2023
• Source: Rigshospitalet, Denmark
• Contact: Reza Jabbari, MD, PhD
• Phone: +4535455380
• Email: reza.jabbari.02[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: October 2032
• Est. primary completion date: October 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Implantable cardioverter defibrillator
Implantation of an ICD for secondary prevention

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Device revision or replacement due to infection or malfunction	Explorative outcome	1 year
Other	Appropriate shock from an ICD (successfully treated VT/VF)	Explorative outcome	1 year
Other	Inappropriate shock from an ICD (shock on non-VT/VF)	Explorative outcome	1 year
Other	Register-based all cause mortality		10 years
Other	Register-based sudden cardiovascular death		5 years
Other	Register-based sudden cardiovascular death		10 years
Other	Register-based cardiovascular death		5 years
Other	Register-based cardiovascular death		10 years
Primary	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	All cause mortality		1 year
Secondary	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
Secondary	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