Coronary Artery DiseaseDanICDNCT04576130
A Danish ICD-study in Patients with Coronary Artery Disease Resuscitated from Ventricular Fibrillation
A study testing Implantable cardioverter defibrillator in people with Coronary Artery Disease and Acute Myocardial Infarction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Myocardial Infarction, Ventricular Fibrillation
- What is being tested?
- Implantable cardioverter defibrillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Oct 2020to Oct 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital, Rigshospitalet
Copenhagen
Reza Jabbari, MD, PhD, +4535455380, reza.jabbari.02@regionh.dk
About this study
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
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%.
- Conditions
- Coronary Artery Disease, Acute Myocardial Infarction, Ventricular Fibrillation, Ventricular Tachycardia, Sustained, Out-Of-Hospital Cardiac Arrest
- Being tested
- Implantable cardioverter defibrillator
- Keywords
- Revascularization, Percutaneous coronary intervention, Implantable cardioverter defibrillator
- Medical subject headings
- Coronary Artery Disease, Ventricular Fibrillation, Tachycardia, Ventricular, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable cardioverter defibrillatorDevice
Also called ICD
Implantation of an ICD for secondary prevention
| Study group | Role | What they receive |
|---|---|---|
| ICD-implantation | Experimental | Implantation of an ICD either during admission or within 4 weeks after discharge from index event. Receives: Device: Implantable cardioverter defibrillator |
| Standard care | No intervention | Guideline directed medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (3)
All cause mortality
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start12 Oct 2020
- Primary completionOct 2032 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reza Jabbari, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Reza Jabbari, MD, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576130
- Sponsor's protocol ID
- H-20007332
- Acronym
- DanICD
- Status last verified
- Jan 2025
- First submitted
- 29 Sep 2020
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04576130
- Acronym / sponsor ID
- DanICD / H-20007332
- Conditions
- Coronary Artery Disease, Acute Myocardial Infarction, Ventricular Fibrillation, Ventricular Tachycardia, Sustained, Out-Of-Hospital Cardiac Arrest
- Keywords
- Revascularization, Percutaneous coronary intervention, Implantable cardioverter defibrillator
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- Oct 2032 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, parallel-group, open-label, superiority trial with two arms with 1:1 randomization through an internet-based randomization module.
| Arm | Type | Receives |
|---|---|---|
| ICD-implantation | Experimental | Device: Implantable cardioverter defibrillatorImplantation of an ICD either during admission or within 4 weeks after discharge from index event. |
| Standard care | No intervention | –Guideline directed medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable cardioverter defibrillatorAlso: ICDImplantation of an ICD for secondary prevention | Device | ICD-implantation |
Primary outcome
All-cause mortality
Time frame: 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.
3 secondary outcomes
All cause mortality
Time frame: 1 year
Sudden cardiovascular death
Time frame: 1 year
Cardiovascular death
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reza Jabbari, MD, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable cardioverter defibrillator in people with Coronary Artery Disease and Acute Myocardial Infarction, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reza Jabbari, MD, PhD (+4535455380, reza.jabbari.02@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.