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Poor recruitment
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| Name | Class |
|---|---|
| Institute for Clinical Evaluative Sciences | OTHER |
| Ontario Ministry of Health and Long Term Care | OTHER_GOV |
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Recent ACC/AHA/ESC guidelines recommend prophylactic ICD implantation in most patients with coronary heart disease and LVEF < 40%. Current Canadian guidelines recommend ICDs for primary prophylaxis in CAD patients with LVEF < 30% (Class I recommendation). There are very sparse data to recommend ICD implantation in patients with EF between 30 and 40 %. This study will randomize patients with CHD and an EF between 30 and 40% to ICD therapy vs. No ICD therapy. The primary outcome is mortality and the study is powered as a non-inferiority trial to test the hypothesis that mortality in patients with no ICD is not more than 1% greater (absolute yearly increase) than patients receiving an ICD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other |
| |
| 2 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optimized medical therapy | Drug | Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | minimum 1 year follow-up (maximum 6 year) |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Presumed arrhythmic (sudden death) mortality. 2. Major morbidity which includes mortality, hospitalization and major device complications | minimum 1 year; maximum 6 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Dorian, MD | Unity Health Toronto | Study Chair |
| Andreas Laupacis, MD | Li Ka Shing Knowledge Institute at St. Michael's Hospital | Study Director |
| Douglas Lee, MD | Institute for Clinical Evaluatuve Sciences | Study Director |
| Kevin Thorpe, MSc | Li Ka Shing Knowledge Institute at St. Michael's Hospital | Study Director |
| Marta Gadacz, MSc | Unity Health Toronto | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences - Hamilton General | Hamilton | Ontario | L8L 2X2 | Canada | ||
| Kingston General Hospital |
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| Implantable Cardioverter Defibrillator | Device | an implanted device, called a defibrillator, which monitors heart rhythm and treats life-threatening rhythms accordingly |
|
|
| Kingston |
| Ontario |
| K7L 2V7 |
| Canada |
| London Health Sciences - University Campus | London | Ontario | N6A 5A5 | Canada |
| Trillium Health Centre - Mississauga | Mississauga | Ontario | L5B 1B8 | Canada |
| Southlake Regional Health Centre | Newmarket | Ontario | L3Y 2P9 | Canada |
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| Rouge Valley Health System - Centenary | Scarborough Village | Ontario | M1E 5E9 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| University Health Network - Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006333 | Heart Failure |
| D018754 | Ventricular Dysfunction |
| D002303 | Cardiac Output, Low |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
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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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