CABG Off or On Pump Revascularization Study - Full Text View

Sponsors and Collaborators:	Population Health Research Institute Hamilton Health Sciences Hotel Dieu Hospital Hopital Notre Dame du CHUM, Montreal, QC Ankara University Fu Wai Hospital, Beijing, China
Information provided by:	Population Health Research Institute
ClinicalTrials.gov Identifier:	NCT00463294

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
Coronary Artery Bypass	Procedure: Coronary Artery Bypass Graft with the use of CPB Procedure: Coronary Artery Bypass Graft without the use of CPB	Phase III

MedlinePlus related topics: Coronary Artery Bypass Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	CABG Off or On Pump Revascularization Study (CORONARY)

Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:

The occurrence of the composite of total mortality, stroke, nonfatal MI, or new renal failure at 30 days post CABG surgery [ Time Frame: 30 days post CABG surgery ]
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. [ Time Frame: 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 ]
The assessment of total costs and resources consumption at 5 years after CABG surgery [ Time Frame: 5 years after CABG surgery ]

Estimated Enrollment:	4700
Study Start Date:	November 2006
Estimated Study Completion Date:	May 2014

Arms	Assigned Interventions
On Pump Arm: Active Comparator	Procedure: Coronary Artery Bypass Graft with the use of CPB
Off Pump Arm: Experimental	Procedure: Coronary Artery Bypass Graft without the use of CPB

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:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463294

Contacts

Contact: Kamil Malikov, MD, MSc, MBA	1 905 527 4322 ext 44533	kmalikov@phri.ca
Contact: Parvez Khatib, MBBS	1 905 527 4322 ext 44412	parvez@phri.ca

Locations

Canada, Ontario
Hamilton General Hospital	Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Joseph Noora, MD, MSc 1 905 527 4432 noora@hhsc.ca
Contact: Toni Rizzo, BScN 1 905 527 4432 ext 44495 rizzot@hhsc.ca
Principal Investigator: Joseph Noora, MD, MSc
Sub-Investigator: Irene Cybulsky, MD FRCSC
Sub-Investigator: Andre Lamy, MD, MSc
Canada, Quebec
Hotel-Dieu du CHUM	Recruiting
Montreal, Quebec, Canada, H2W 1T8
Contact: Carol Lemay 1-514-890-8000 ext 14803
Principal Investigator: Nicholas Noiseux, MD
Hopital Notre Dame du CHUM	Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Michel Vigneault 1-514-890-8000 ext 25072
Principal Investigator: Louis Normandin, MD

Sponsors and Collaborators

Population Health Research Institute

Hamilton Health Sciences

Hotel Dieu Hospital

Hopital Notre Dame du CHUM, Montreal, QC

Ankara University

Fu Wai Hospital, Beijing, China

Investigators

Principal Investigator:	Lamy Andre, MD, MSc	McMaster University
Principal Investigator:	Salim Yusuf, MD, DPhil	Population Health Research Institute
Principal Investigator:	Philip J. Devereaux, MD	McMaster University

More Information

Study ID Numbers:	PHRI-065
Study First Received:	April 18, 2007
Last Updated:	September 4, 2007
ClinicalTrials.gov Identifier:	NCT00463294
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Population Health Research Institute:

CABG
On-pump
Off-pump

ClinicalTrials.gov processed this record on January 16, 2009