Coronary Artery Bypass Surgery (CABG) Off or On Pump Revascularization Study (CORONARY)
I. Main Research Question:
- To compare the risks and benefits of Off-pump Coronary artery bypass surgery (CABG) to On-pump CABG and to determine if one is better than the other.
- The purpose of this pilot study is also to see the rate of recruitment with expertise-based randomization across different hospital settings.
II. Small RCT studies and meta-analyses done so far have not been able to conclusively say which of the procedure is better. A large randomized study is required to establish the risks and benefits associated with both the off-pump and on-pump CABG surgical procedures.
III. The study will look at which of the two techniques reduce major risks associated with CABG.
|the Efficacy and Safety of Off-pump CABG||Procedure: Coronary Artery Bypass Graft with the use of CPB Procedure: Coronary Artery Bypass Graft without the use of CPB||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CABG Off or On Pump Revascularization Study (CORONARY)|
- First Co-Primary Outcome [ Time Frame: 30 days post CABG surgery ]The occurrence of the composite of total mortality, stroke, nonfatal MI, or new renal failure at 30 days post CABG surgery
- Second co-primary outcome [ Time Frame: 5 years after CABG ]The occurrence of the composite of total mortality, stroke, nonfatal MI, new renal failure, or repeat coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention) over 5 years after randomization.
- The assessment of total costs and resources consumption at 30 days after CABG surgery [ Time Frame: 30 days after CABG surgery ]
- The assessment of total costs and resources consumption at 5 years after CABG surgery [ Time Frame: 5 years after CABG surgery ]
|Study Start Date:||October 2007|
|Study Completion Date:||September 2016|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: On Pump Arm||
Procedure: Coronary Artery Bypass Graft with the use of CPB
Coronary Artery Bypass Graft (CABG) using median sternotomy, CPB, cardioplegia and complete cross-clamp and no associated or concomitant surgical procedures
Other Name: ON Pump CABG
|Experimental: Off Pump Arm||
Procedure: Coronary Artery Bypass Graft without the use of CPB
Coronary Artery Bypass Graft (CABG) with no associated or concomitant surgical procedures, using median sternotomy and without CPB and cardioplegia
Other Name: OFF Pump
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00463294
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|Principal Investigator:||Lamy Andre, MD, MSc||McMaster University|
|Principal Investigator:||Salim Yusuf, MD, DPhil||Population Health Research Institute|
|Principal Investigator:||David Taggart, MD||University of Oxford|