A Danish ICD-study in Patients with Coronary Artery Disease Resuscitated from Ventricular Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implantable cardioverter defibrillator.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease, Acute Myocardial Infarction, Ventricular Fibrillation, Ventricular Tachycardia, Sustained. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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%.
Interventions
- Device Implantable cardioverter defibrillator
Implantation of an ICD for secondary prevention
Primary outcome measures
- All-cause mortality [Time frame: 5 years]
Secondary outcome measures (3)
- All cause mortality [Time frame: 1 year]
- Sudden cardiovascular death [Time frame: 1 year]
- Cardiovascular death [Time frame: 1 year]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- Copenhagen University Hospital, Rigshospitalet — Copenhagen
Identifiers
NCT: NCT04576130 · H-20007332