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Randomized Clinical Trial Comparing Coronary Bypass Grafting With or Without Cardiopulmonary Bypass
This study has been completed.

First Received on September 19, 2005.   No Changes Posted
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

Resource links provided by NLM:


Further study details as provided by Maritime Heart Centre:

Primary Outcome Measures:
  • Length of hospitalization
  • Blood product utilization
  • Post operative atrial fibrillation

Secondary Outcome Measures:
  • Myocardial infarction
  • Mortality

Estimated Enrollment: 300
Study Start Date: October 1998
Estimated Study Completion Date: June 2004
Detailed Description:

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
Criteria

Inclusion Criteria:

  • Any patient suitable for CABG surgery

Exclusion Criteria:

  • Emergency, concomitant procedure, low ejection fraction (<20%)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00216957

Locations
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Maritime Heart Centre
Investigators
Principal Investigator: Jean-Francois Legare, MD Dalhousie University
  More Information

No publications provided

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012