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%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,200
Implantation of an ICD for secondary prevention
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
RECRUITINGAll-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.
Time frame: 5 years
All cause mortality
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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