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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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD-implantation | Experimental | Implantation of an ICD either during admission or within 4 weeks after discharge from index event. |
|
| Standard care | No Intervention | Guideline directed medical therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable cardioverter defibrillator | Device | Implantation of an ICD for secondary prevention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 1 year | |
| Sudden cardiovascular death | Cardiovascular death fulfilling the following criteria:
|
| Measure | Description | Time Frame |
|---|---|---|
| Device revision or replacement due to infection or malfunction | Explorative outcome | 1 year |
| Appropriate shock from an ICD (successfully treated VT/VF) | Explorative outcome |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reza Jabbari, MD, PhD | Contact | +4535455380 | reza.jabbari.02@regionh.dk | |
| Thomas Engstrøm, MD, PhD, DMSc | Contact | +4535458444 | thomas.engstroem@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Reza Jabbari, MD, PhD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Rigshospitalet | Recruiting | Copenhagen | Denmark |
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Randomized, parallel-group, open-label, superiority trial with two arms with 1:1 randomization through an internet-based randomization module.
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Treatment cannot be blinded, we will use several endpoints that do not require an endpoint committee evaluation.
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| 1 year |
| Cardiovascular death | Mortality is considered as cardiovascular unless it is clearly attributable to another cause and thus includes:
| 1 year |
| 1 year |
| Inappropriate shock from an ICD (shock on non-VT/VF) | Explorative outcome | 1 year |
| Register-based all cause mortality | 10 years |
| Register-based sudden cardiovascular death | 5 years |
| Register-based sudden cardiovascular death | 10 years |
| Register-based cardiovascular death | 5 years |
| Register-based cardiovascular death | 10 years |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D014693 | Ventricular Fibrillation |
| D017180 | Tachycardia, Ventricular |
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
| D006323 | Heart Arrest |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D004567 | Electrodes, Implanted |
| D019736 | Prostheses and Implants |
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