Randomized Clinical Trial Comparing Coronary Bypass Grafting With or Without Cardiopulmonary Bypass

Ischemic Heart Disease Clinical Trial

Official title:

Randomized Clinical Trial Comparing Coronary Bypass Grafting With or Without Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216957
• Other study ID #: QE-RS/1998-220
• Status: Completed
• Phase: Phase 3
• First received: September 19, 2005
• Last updated: September 19, 2005
• Start date: October 1998
• Est. completion date: June 2004

Study information

• Verified date: September 2005
• Source: Maritime Heart Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any patient suitable for CABG surgery

Exclusion Criteria:

• Emergency, concomitant procedure, low ejection fraction (<20%)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Procedure:
• Coronary bypass surgery without cardiopulmonary bypass

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Center	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Maritime Heart Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospitalization
Primary	Blood product utilization
Primary	Post operative atrial fibrillation
Secondary	Myocardial infarction
Secondary	Mortality