Plain English Summary
Not provided at time of registration
Trial website
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22172429
2. 2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22449296
3. 2012 sub-study protocol in: https://www.ncbi.nlm.nih.gov/pubmed/22514244
4. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23477676
5. 2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24886787
6. 2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/25261272
7. 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27771985