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Coronary Artery Bypass Surgery (CABG) Off or On Pump Revascularization Study (CORONARY)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
McMaster University
University of Oxford
Instituto Dante Pazzanese de Cardiologia
ECLA Clinical Research Organization,
Fu Wai Hospital, Beijing, China
Facultad de Medicina, Universidad de La Frontera, Temuco, Chile
Fundación Cardiovascular de Colombia
Charles University, Czech Republic
Hopital Jean Minjoz
Centre for Chronic Disease Control, India
S. C. di Cardiochirurgia, Ospedale Santa Croce a Carle, Cuneo, Italy
Medical University of Gdansk
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Ankara University
Hotel Dieu Hospital
Centre hospitalier de l'Université de Montréal (CHUM)
SAL Hospital, Ahmedabad, India
Information provided by (Responsible Party):
Andre Lamy, Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT00463294
First received: April 18, 2007
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
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 Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CABG Off or On Pump Revascularization Study (CORONARY)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • First Co-Primary Outcome [ Time Frame: 30 days post CABG surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • The assessment of total costs and resources consumption at 30 days after CABG surgery [ Time Frame: 30 days after CABG surgery ] [ Designated as safety issue: No ]
  • The assessment of total costs and resources consumption at 5 years after CABG surgery [ Time Frame: 5 years after CABG surgery ] [ Designated as safety issue: No ]

Enrollment: 4752
Study Start Date: October 2007
Estimated Study Completion Date: May 2015
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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> 21 years of age and

  4. 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463294

  Show 52 Study Locations
Sponsors and Collaborators
Population Health Research Institute
McMaster University
University of Oxford
Instituto Dante Pazzanese de Cardiologia
ECLA Clinical Research Organization,
Fu Wai Hospital, Beijing, China
Facultad de Medicina, Universidad de La Frontera, Temuco, Chile
Fundación Cardiovascular de Colombia
Charles University, Czech Republic
Hopital Jean Minjoz
Centre for Chronic Disease Control, India
S. C. di Cardiochirurgia, Ospedale Santa Croce a Carle, Cuneo, Italy
Medical University of Gdansk
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Ankara University
Hotel Dieu Hospital
Centre hospitalier de l'Université de Montréal (CHUM)
SAL Hospital, Ahmedabad, India
Investigators
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
  More Information

No publications provided by Population Health Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Andre Lamy, Cardiac Surgeon, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT00463294     History of Changes
Other Study ID Numbers: PHRI-065
Study First Received: April 18, 2007
Last Updated: April 17, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Population Health Research Institute:
CABG
On-pump
Off-pump

ClinicalTrials.gov processed this record on May 22, 2013