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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04576130
Other study ID # H-20007332
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 12, 2020
Est. completion date October 2032

Study information

Verified date November 2023
Source Rigshospitalet, Denmark
Contact Reza Jabbari, MD, PhD
Phone +4535455380
Email reza.jabbari.02@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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%.


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date October 2032
Est. primary completion date October 2032
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Implantable cardioverter defibrillator
Implantation of an ICD for secondary prevention

Locations

Country Name City State
Denmark Copenhagen University Hospital, Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Device revision or replacement due to infection or malfunction Explorative outcome 1 year
Other Appropriate shock from an ICD (successfully treated VT/VF) Explorative outcome 1 year
Other Inappropriate shock from an ICD (shock on non-VT/VF) Explorative outcome 1 year
Other Register-based all cause mortality 10 years
Other Register-based sudden cardiovascular death 5 years
Other Register-based sudden cardiovascular death 10 years
Other Register-based cardiovascular death 5 years
Other Register-based cardiovascular death 10 years
Primary All-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. 5 years
Secondary All cause mortality 1 year
Secondary 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.
1 year
Secondary 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.
1 year
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