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

ISRCTN	ISRCTN84724990
DOI	https://doi.org/10.1186/ISRCTN84724990
ClinicalTrials.gov number	NCT00463294
Secondary identifying numbers	MCT-85214; 5999

Submission date: 04/02/2008
Registration date: 04/02/2008
Last edited: 03/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Andre Lamy
Scientific

Hamilton General Hospital
237 Barton St. E.
McMaster Clinic Room 704
Hamilton, Ontario
L8L 2X2
Canada

Phone	+1 905 522 0175
Email	lamya@mcmaster.ca

Study information

Study design	International unblinded multicentre two arm randomised parallel surgical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Coronary artery bypass graft (CABG) off- or on-pump revascularisation study
Study acronym	CORONARY
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
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 study start date	01/10/2007
Completion date	31/05/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 4700; UK Sample Size: 250
Key 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)
Key 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
Date of first enrolment	01/10/2007
Date of final enrolment	31/05/2014

Locations

Countries of recruitment

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

Study participating centre

Hamilton General Hospital

Hamilton, Ontario
L8L 2X2
Canada

Sponsor information

Population Health Research Institute (PHRI) (Canada)
Research organisation

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

Website	http://www.ccc.mcmaster.ca/
"ROR"	https://ror.org/03kwaeq96

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/01/2012	Yes	No
Protocol article	sub-study protocol	18/04/2012	Yes	No
Results article	results	19/04/2012	Yes	No
Results article	results	28/03/2013	Yes	No
Results article	results	04/06/2014	Yes	No
Results article	results	01/11/2014	Yes	No
Results article	results	15/12/2016	Yes	No

Editorial Notes

03/04/2019: Publication references added.
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.