Condition category
Circulatory System
Date applied
04/02/2008
Date assigned
04/02/2008
Last edited
18/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ccc.mcmaster.ca/coronary.htm

Contact information

Type

Scientific

Primary contact

Dr Andre Lamy

ORCID ID

Contact details

Hamilton General Hospital
237 Barton St. E.
McMaster Clinic Room 704
Hamilton
Ontario
L8L 2X2
Canada
+1 905 522 0175
lamya@mcmaster.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00463294

Protocol/serial number

MCT-85214; 5999

Study information

Scientific title

Coronary artery bypass graft (CABG) off- or on-pump revascularisation study

Acronym

CORONARY

Study hypothesis

Primary hypothesis:
In patients undergoing coronary artery bypass graft (CABG) surgery, off-pump CABG surgery compared to on-pump CABG surgery reduces major clinical vascular events in the short term (30 days) and these benefits are maintained at long term (5 years).

Secondary hypothesis:
In patients undergoing CABG surgery, off-pump CABG surgery compared to on-pump CABG surgery reduces costs in the short term (30 days) and at long term (5 years).

Ethics approval

Ethics approval received from:
1. Canada: Research Ethics Board of Hamilton Health Sciences/McMaster University, Hamilton, Ontario on the 30th March 2007 (final approval for pilot) and 19th June 2007 (re-consent for long term follow-up) (ref: 06-045)
2. Brazil: Comite de Etica em Pesquisa, Institute Dante Pazzanese on the 6th November 2007 (ref: CEP 3581)
3. Colombia: Comité de Ética en Investigación , Fundacion Cardiovascular Del Oriente Colombiano, Floridablanca (SS) on the 23rd January 2008
4. France: Comité de Protection des Personnes, CHU-Hôpital Saint Jacques on the 26th June 2007 (ref: 07/446)
5. Turkey: Research Ethics Committee of Medical Faculty, Ankara University, Ankara on the 7th January 2008 (ref: 123-3353)
6. Chile: Gobierno De Chile, Servicio de Salud Metropolitano Oriente, Comité de Ética Científico, Santiago on the 20th January 2008
7. China: Ethics Committee FuWai Hospital, Beijing in May 2007
8. Czech Republic: Eticka Komise, Fakulni nemocnice Kralovske Vinohrady, Prague on the 9th January 2008
9. India: Ethics Committee All India Institute of Medical Sciences, Delhi on the 10th April 2008
10. Italy: Comitao Etico Intraziendale, Azienda Ospedaliera S. Croce e Carle, Cuneo on the 4th April 2008
11. Poland: Niezna Komisia Bioetyczna, Akademia Medyczna, Gdansk on the 15th May 2008
12. Ukraine: Komitet z medicnoi etiki, M.M. Amosov Government Facility, National Institute of Cardio-vascular Surgery on the 26th June 2008
13: United Kingdom: MREC approved (ref: 08/H0604/48)

Ethics approval pending as of 26/04/2010 from:
14. Slovak Republic
15. Argentina
16. Netherlands

Study design

International unblinded multicentre two arm randomised parallel surgical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Coronary artery disease requiring isolated coronary artery bypass graft (CABG)

Intervention

Coronary artery bypass graft (CABG) surgery with or without cardio-pulmonary bypass (CPB) machine:
1. Experimental group: CABG without use of CPB
2. Control group: CABG with the use of CPB

Contact for public queries (except for UK component):
Kamil Malikov
Email: kmalikov@ccc.mcmaster.ca

Parvez Khatib
Email: parvez@ccc.mcmaster.ca

Contact details for UK component:
Ms Carol Wallis
carol.wallis@nds.ox.ac.uk

Sponsor details for UK component:
University of Oxford (UK)
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
http://www.ox.ac.uk/

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. The occurrence of the composite of total mortality, stroke, nonfatal myocardial infarction [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 revascularisation (i.e. coronary artery bypass surgery or percutaneous coronary intervention) over 5 years after randomisation

Secondary outcome measures

1. The assessment of total costs and resources consumption at 30 days after CABG surgery
2. The assessment of total costs and resources consumption at 5 years after CABG surgery

Overall trial start date

01/10/2007

Overall trial end date

31/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Require isolated CABG with median sternotomy
2. Provide written informed consent
3. 21 years of age and older, either sex
4. Have one risk factor or more:
4.1. Greater than or equal to 70 years age
4.2. Peripheral vascular disease (previous peripheral bypass or amputation or ankle brachial index [ABI] less than 0.80)
4.3. Cerebrovascular disease (history of stroke, transient ischaemic attack [TIA], carotid stenosis greater than 70%)
4.4. Renal insufficiency (creatinine above upper limit of normal)
4.5. Greater than 60 years of age with one of the following:
4.5.1. Diabetes (oral hypoglycaemic agent and/or insulin)
4.5.2. Urgent revascularisation (waiting in hospital)
4.5.3. Left ventricular ejection fraction less than 35%
4.5.4. Current or recent smokers (within 1 year of randomisation)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 4700; UK Sample Size: 250

Participant exclusion criteria

1. Concomitant cardiac procedure associated with CABG
2. Contra-indications to off-pump CABG or on-pump CABG (calcified aorta, intramuscular left anterior descending [LAD], calcified coronaries, small target vessels)
3. Concomitant life-threatening disease likely to limit life expectancy to less than 2 years
4. Prior enrolment in this trial
5. Emergency CABG surgery (immediate revascularisation for haemodynamic instability)
6. Redo CABG

Recruitment start date

01/10/2007

Recruitment end date

31/05/2014

Locations

Countries of recruitment

Argentina, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, India, Italy, Netherlands, Poland, Slovakia, Turkey, Ukraine, United Kingdom

Trial participating centre

Hamilton General Hospital
Hamilton, Ontario
L8L 2X2
Canada

Sponsor information

Organisation

Population Health Research Institute (PHRI) (Canada)

Sponsor details

McMaster University
General Site
237 Barton Street East
Hamilton
Ontario
L8L 2X2
Canada

Sponsor type

Research organisation

Website

http://www.ccc.mcmaster.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-85214)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/11/2016: No publications found in PubMed, verifying study status with principal investigator. 26/04/2010: This record was updated to include the UK component of this trial 25/07/2008: Ethics approval information was added for the following countries: Chile, China, Czech Republic, India, Italy, Poland, Ukraine. Please also note that the countries of recruitment were updated. The previous countries of recruitment were Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Hungary, India, Italy, Netherlands, Poland, Switzerland, Turkey, Ukraine, United Kingdom.