Status:
COMPLETED
Coronary Artery Bypass Surgery (CABG) Off or On Pump Revascularization Study
Lead Sponsor:
Population Health Research Institute
Collaborating Sponsors:
McMaster University
University of Oxford
Conditions:
the Efficacy and Safety of Off-pump CABG
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
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 thi...
Detailed Description
Rationale and purpose of the study: Coronary artery bypass grafting (CABG) surgery prolongs life-expectancy in patients with severe ischemic heart disease, especially those with left main, triple ves...
Eligibility Criteria
Inclusion
- Patients who have been diagnosed with coronary artery disease (single, double or triple disease) will be eligible if they:
- require isolated CABG with median sternotomy
- are able to give their informed written consent
- are\> 21 years of age and
- have one or more of the following risk factors:
- ≥ 70 years
- peripheral vascular disease (previous peripheral bypass or amputation or ABI \<0.80)
- Cerebrovascular disease (history of stroke, TIA)
- Renal insufficiency (creatinine above upper limit of normal)
- \>60 years of age and one of the following:
- diabetes (oral hypoglycemic agent and/or insulin)
- urgent revascularization (waiting in hospital)
- LV ejection fraction \<35%
- current or recent smoker.
- 55-59 years of age and two of the following:
- diabetes (oral hypoglycemic agent and/or insulin)
- urgent revascularization (waiting in hospital)
- LV ejection fraction \<35%
- current or recent smoker.
Exclusion
- Patients will be excluded if they have one of the following:
- concomitant cardiac procedure associated with CABG,
- contra-indications to off-pump CABG or on-pump CABG (calcified aorta, intramuscular LAD, calcified coronaries, small target vessels)
- concomitant life-threatening disease likely to limit life expectancy to less than 2 years,
- prior enrollment in this trial
- emergency CABG surgery (immediate revascularization for hemodynamic instability) OR
- redo CABG.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
4752 Patients enrolled
Trial Details
Trial ID
NCT00463294
Start Date
October 1 2007
End Date
September 1 2016
Last Update
September 16 2016
Active Locations (52)
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1
Fundacion Medica de rio negro y neuquen
Rio Negro, Argentina
2
Beneficencia Portuguesa de Sao Paulo
São Paulo, CEP, Brazil, 01323.001
3
Instituto Dante Pazzanese de Cardiologia
São Paulo, CEP, Brazil, 04012-909
4
Hospital Sao Francisco Complexo Hospitalar Santa Casa
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090