Back to resultsA Danish ICD-study in Patients With Coronary Artery Disease Resuscitated From Ventricular Fibrillation (DanICD)
Primary Purpose
Coronary Artery Disease, Acute Myocardial Infarction, Ventricular Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Implantable cardioverter defibrillator
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring Revascularization, Percutaneous coronary intervention, Implantable cardioverter defibrillator
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
Sites / Locations
- Copenhagen University Hospital, RigshospitaletRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ICD-implantation
Standard care
Arm Description
Implantation of an ICD either during admission or within 4 weeks after discharge from index event.
Guideline directed medical therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
All cause mortality
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.
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.
Full Information
NCT ID
NCT04576130
First Posted
September 29, 2020
Last Updated
October 25, 2022
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04576130
Brief Title
A Danish ICD-study in Patients With Coronary Artery Disease Resuscitated From Ventricular Fibrillation
Acronym
DanICD
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
October 2032 (Anticipated)
Study Completion Date
October 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Acute Myocardial Infarction, Ventricular Fibrillation, Ventricular Tachycardia, Sustained, Out-Of-Hospital Cardiac Arrest
Keywords
Revascularization, Percutaneous coronary intervention, Implantable cardioverter defibrillator
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, parallel-group, open-label, superiority trial with two arms with 1:1 randomization through an internet-based randomization module.
Masking
None (Open Label)
Masking Description
Treatment cannot be blinded, we will use several endpoints that do not require an endpoint committee evaluation.
Allocation
Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICD-implantation
Arm Type
Experimental
Arm Description
Implantation of an ICD either during admission or within 4 weeks after discharge from index event.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Guideline directed medical therapy
Intervention Type
Device
Intervention Name(s)
Implantable cardioverter defibrillator
Other Intervention Name(s)
ICD
Intervention Description
Implantation of an ICD for secondary prevention
Primary Outcome Measure Information:
Title
All-cause mortality
Description
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
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
1 year
Title
Sudden cardiovascular death
Description
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
Title
Cardiovascular death
Description
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
Other Pre-specified Outcome Measures:
Title
Device revision or replacement due to infection or malfunction
Description
Explorative outcome
Time Frame
1 year
Title
Appropriate shock from an ICD (successfully treated VT/VF)
Description
Explorative outcome
Time Frame
1 year
Title
Inappropriate shock from an ICD (shock on non-VT/VF)
Description
Explorative outcome
Time Frame
1 year
Title
Register-based all cause mortality
Time Frame
10 years
Title
Register-based sudden cardiovascular death
Time Frame
5 years
Title
Register-based sudden cardiovascular death
Time Frame
10 years
Title
Register-based cardiovascular death
Time Frame
5 years
Title
Register-based cardiovascular death
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reza Jabbari, MD, PhD
Phone
+4535455380
Email
reza.jabbari.02@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Engstrøm, MD, PhD, DMSc
Phone
+4535458444
Email
thomas.engstroem@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Jabbari, MD, PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital, Rigshospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reza Jabbari, MD, PhD
Phone
+4535455380
Email
reza.jabbari.02@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Danish ICD-study in Patients With Coronary Artery Disease Resuscitated From Ventricular Fibrillation
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