Actively Recruiting
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
Led by Rigshospitalet, Denmark · Updated on 2025-01-27
1200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the potential benefits of implanting an implantable cardioverter defibrillator (ICD) in patients with coronary artery disease who have survived cardiac arrest caused by ventricular fibrillation or sustained ventricular tachycardia. These patients have undergone complete revascularization and have a left ventricular ejection fraction (LVEF) above 35%. The study aims to assess whether ICD implantation can improve survival outcomes compared to standard medical therapy. Participants are randomly assigned to one of two groups: one group receives an ICD implanted either during admission or within 4 weeks after discharge from the initial cardiac event, while the other group receives guideline-directed medical therapy without ICD implantation. The study compares these approaches to understand the effect of ICDs on survival in this patient population. During the study, participants will be monitored for outcomes including all-cause mortality over a five-year period, as well as mortality related to cardiovascular causes at one year. Researchers will collect data on sudden cardiovascular death and cardiovascular death within the first year. The trial includes follow-up assessments to track these outcomes and the overall health of participants throughout the study duration.
CONDITIONS
Brief Title
A Danish ICD-study in Patients with Coronary Artery Disease Resuscitated from Ventricular Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with coronary artery disease and cardiac arrest due to ventricular fibrillation or sustained ventricular tachycardia, who have undergone angiogram with complete revascularization before ICD implantation
- Age 18 years or older
- Left ventricular ejection fraction (LVEF) above 35% at the time of discharge, based on the most recent assessment used for current medical treatment
You will not qualify if you...
- Cardiac arrest due to non-ischemic causes such as ion channel diseases or non-ischemic cardiomyopathy
- Previous coronary artery bypass grafting (CABG) within 3 months before the current hospitalization
- Life expectancy less than 1 year or severe neurologic outcome
- Unable or unwilling to provide informed consent
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks after discharge
Participants receive implantation of an implantable cardioverter defibrillator (ICD) either during admission or within 4 weeks after discharge from the initial cardiac event.
1 to 2 visits depending on timing of implantation
Duration - Up to 5 years
Participants are monitored for up to 5 years to assess all-cause mortality and cardiovascular outcomes following ICD implantation or standard medical therapy.
Periodic visits during follow-up up to 5 years
Trial Site Locations
Total: 1 location
1
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
Research Team
R
Reza Jabbari, MD, PhD
T
Thomas Engstrøm, MD, PhD, DMSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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