Assessing the benefits of ICD implantation in patients with coronary artery disease after cardiac arrest
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
This study is testing if getting an implantable defibrillator helps people with coronary artery disease who have survived a cardiac arrest feel better and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT04576130 on ClinicalTrials.gov |
What this trial studies
This study evaluates whether implantable cardioverter defibrillator (ICD) implantation provides benefits to patients with coronary artery disease who have survived cardiac arrest due to ventricular fibrillation or sustained ventricular tachycardia. Participants will undergo complete revascularization before receiving the ICD, and the study will focus on those with a left ventricular ejection fraction (LVEF) above 35%. The aim is to determine the effectiveness of ICDs in improving outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with coronary artery disease who have survived cardiac arrest due to ventricular fibrillation or sustained ventricular tachycardia and have undergone complete revascularization.
Not a fit: Patients with non-ischemic causes of cardiac arrest or those with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve survival rates and quality of life for patients with coronary artery disease who experience cardiac arrest.
How similar studies have performed: Previous studies have shown promising results with ICD implantation in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen
- Copenhagen University Hospital, Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Reza Jabbari, MD, PhD — Rigshospitalet, Denmark
- Study coordinator: Reza Jabbari, MD, PhD
- Email: reza.jabbari.02@regionh.dk
- Phone: +4535455380
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.