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| Sponsor: | Maritime Heart Centre |
|---|---|
| Information provided by: | Maritime Heart Centre |
| ClinicalTrials.gov Identifier: | NCT00216957 |
Purpose
Coronary artery bypass grafting (CABG) is a well established treatment modality for patients with coronary artery disease. For 30 years now CABG operations have been performed with the help of the heart lung machine (Cardiopulmonary bypass). However, the heart lung machine is believed to be responsible for many of the side effects and complications seen in patients following CABG surgery. The organs most commonly affected are the brain, blood constituents, lungs and kidneys.
In the last few years, stabilising devices have been developed that allow CABG operations to be performed safely without the use of the heart lung machine. Our hypothesis was that CABG done without the heart lung machine may be better tolerated by patients resulting in lower morbidity, increased functional outcome and shorter hospital length of stay.
Enrolment into the trial was from 1998 to 2003 and included 300 patients. The last patient was enrolled in June of 2003. The initial results from the study suggest that excellent results can be obtained with both techniques and contrary to others no advantages could be demonstrated in in-hospital outcomes of patients performed without cardiopulmonary bypass (Legare et al. Circulation 2005).
| Condition | Intervention | Phase |
|---|---|---|
|
Ischemic Heart Disease |
Procedure: Coronary bypass surgery without cardiopulmonary bypass |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Clinical Trial Comparing Coronary Bypass Grafting With or Without Cardiopulmonary Bypass |
| Estimated Enrollment: | 300 |
| Study Start Date: | October 1998 |
| Estimated Study Completion Date: | June 2004 |
We are now in follow-up to evaluate the medium term and long term outcomes of all 300 patients originally enrolled in above mentioned randomized clinical trial. The follow-up of patients is approved by the Capital Health Research Ethics Board (CDHA-RS/2004-295).
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Nova Scotia | |
| Queen Elizabeth II Health Sciences Center | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Principal Investigator: | Jean-Francois Legare, MD | Dalhousie University |
More Information
| ClinicalTrials.gov Identifier: | NCT00216957 History of Changes |
| Other Study ID Numbers: | QE-RS/1998-220 |
| Study First Received: | September 19, 2005 |
| Last Updated: | September 19, 2005 |
| Health Authority: | Canada: Health Canada |
|
Coronary Artery Disease Myocardial Ischemia Heart Diseases Coronary Disease |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |