| August 29, 2007 |
| January 5, 2009 |
| October 2007 |
| April 2011 (final data collection date for primary outcome measure) |
| All-cause mortality [ Time Frame: minimum 1 year follow-up (maximum 6 year) ] [ Designated as safety issue: No ] |
| All-cause mortality [ Time Frame: minimum 1 year follow-up (maximum 6 year) ] |
| Complete list of historical versions of study NCT00524862 on ClinicalTrials.gov Archive Site |
| 1. Presumed arrhythmic (sudden death) mortality.
2. Major morbidity which includes mortality, hospitalization and major device complications [ Time Frame: minimum 1 year; maximum 6 years ] [ Designated as safety issue: No ] |
| 1. Presumed arrhythmic (sudden death) mortality.
2. Major morbidity which includes mortality, hospitalization and major device complications [ Time Frame: minimum 1 year; maximum 6 years ] |
| |
| Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death |
| Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD |
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. |
| |
| |
| Interventional |
| Prevention, Randomized, Open Label, Active Control, Parallel Assignment |
- Coronary Heart Disease
- Congestive Heart Failure
- Ventricular Dysfunction
- Low Cardiac Output
- Sudden Cardiac Death
|
- Drug: Optimized medical therapy
- Device: Implantable Cardioverter Defibrillator
|
| |
| |
| |
| Terminated |
| 5000 |
| April 2011 |
| April 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- documented chronic coronary heart disease (prior MI and/or angiographically documented CAD), > 40 days post the most recent MI;
- LVEF < 40% (by MUGA) and NYHA functional class II or III at time of assessment OR LVEF ≤ 35 % (by MUGA) and NYHA functional class I, II or III at time of assessment
- Judged to have a reasonable expectation of survival with a good functional status for more than 1 year, as well as receiving optimum, guideline recommended therapy for coronary artery disease and heart failure (or demonstrated intolerance or contraindications to such therapy).
- Age ≥ 18 years; no upper age limitation.
Exclusion Criteria:
- Prior cardiac arrest, sustained VT or VF, or unexplained syncope.
- Attempted VT / VF induction at electrophysiological study.
- Need for a cardiac resynchronization therapy (CRT) device.
- Enrollment in another interventional trial.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Canada |
| |
| NCT00524862 |
| Prinicipal Investigator, St. Michael's Hospital |
| 06368 |
| St. Michael's Hospital, Toronto |
- Institute for Clinical Evaluative Sciences
- Ontario Ministry of Health and Long Term Care
|
| Study Chair: |
Paul Dorian, MD |
St. Michael's Hospital, Toronto |
|
| Study Director: |
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 |
St. Michael's Hospital, Toronto |
|
|
| St. Michael's Hospital, Toronto |
| May 2008 |
