Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery Health Condition 2: null- Coronary artery disease
Conditions
Interventions
Control Intervention1: 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
Sponsors
Population Health Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: Patients who have been diagnosed with coronary artery disease (single, double or triple disease) will be eligible if they: 1.require isolated CABG with median sternotomy 2.are able to give their informed written consent 3.are above 21 years of age and 4.have one or more of the following risk factors: â?¦above or equal to 70 years â?¦peripheral vascular disease (previous peripheral bypass or amputation or ABI less than 0.80) â?¦Cerebrovascular disease (history of stroke, TIA) â?¦Renal insufficiency (creatinine above upper limit of normal) â?¦above 60 years of age and one of the following: â? diabetes (oral hypoglycemic agent and/or insulin) â? urgent revascularization (waiting in hospital) â? LV ejection fraction below 35 percent â? current or recent smoker. â?¦55-59 years of age and two of the following: â? diabetes (oral hypoglycemic agent and/or insulin) â? urgent revascularization (waiting in hospital) â? LV ejection fraction below 35 percent â? current or recent smoker.
Exclusion criteria
Exclusion criteria: Patients will be excluded if they have one of the following: 1.concomitant cardiac procedure associated with CABG, 2.contra-indications to off-pump CABG or on-pump CABG (calcified aorta, intramuscular LAD, calcified coronaries, small target vessels) 3.concomitant life-threatening disease likely to limit life expectancy to less than 2 years, 4.prior enrollment in this trial 5.emergency CABG surgery (immediate revascularization for hemodynamic instability) OR 6.redo CABG.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The occurrence of the composite of total mortality, stroke, nonfatal MI, or new renal failure at 30 days post CABG surgery 2. 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 randomizationTimepoint: 1. 30 days post CABG surgery 2. 5 years after CABG | — |
Secondary
| Measure | Time frame |
|---|---|
| The assessment of total costs and resources consumption at 30 days after CABG surgeryTimepoint: 30 days after CABG surgery;The assessment of total costs and resources consumption at 5 years after CABG surgeryTimepoint: 5 years after CABG surgery | — |
Countries
Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Estonia, France, India, Italy, Netherlands, Sweden, Turkey, Ukraine, United Kingdom, United States of America, Uruguay
Contacts
Public ContactDorairaj Prabhakaran India
Centre for Chronic Disease Control
Outcome results
None listed