Acute Myocardial Infarction, Coronary Artery Disease, Out-Of-Hospital Cardiac Arrest, Ventricular Fibrillation, Ventricular Tachycardia, Sustained
Conditions
Keywords
Revascularization, Percutaneous coronary intervention, Implantable cardioverter defibrillator
Brief 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%.
Interventions
DEVICEImplantable cardioverter defibrillator
Implantation of an ICD for secondary prevention
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Treatment cannot be blinded, we will use several endpoints that do not require an endpoint committee evaluation.
Intervention model description
Randomized, parallel-group, open-label, superiority trial with two arms with 1:1 randomization through an internet-based randomization module.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | 1 year | — |
| Sudden cardiovascular death | 1 year | 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. |
| Cardiovascular death | 1 year | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Register-based sudden cardiovascular death | 5 years | — |
| Device revision or replacement due to infection or malfunction | 1 year | Explorative outcome |
| Register-based cardiovascular death | 5 years | — |
| Appropriate shock from an ICD (successfully treated VT/VF) | 1 year | Explorative outcome |
| Inappropriate shock from an ICD (shock on non-VT/VF) | 1 year | Explorative outcome |
| Register-based all cause mortality | 10 years | — |
Countries
Denmark
Contacts
Primary ContactReza Jabbari, MD, PhD
Backup ContactThomas Engstrøm, MD, PhD, DMSc
Outcome results
None listed