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| [ ...Back to search results ] | [ Print-friendly version ] |
| Coronary artery bypass graft (CABG) off- or on-pump revascularisation study |
| ISRCTN | ISRCTN84724990 |
| ClinicalTrials.gov identifier | NCT00463294 |
| Public title | Coronary artery bypass graft (CABG) off- or on-pump revascularisation study |
| Scientific title | |
| Acronym | CORONARY |
| Serial number at source | MCT-85214; 5999 |
| 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). Please note that as of 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. As of 26/04/2010 this record was updated to include the UK component of this trial. |
| Lay summary | Not provided at time of registration |
| 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, multicentre, two arm, randomised parallel surgical trial, no blinding. |
| Countries of recruitment | Argentina, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, India, Italy, Netherlands, Poland, Slovakia, Turkey, Ukraine, United Kingdom |
| Disease/condition/study domain | Coronary artery disease requiring isolated coronary artery bypass graft (CABG) |
| Participants - 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) |
| Participants - 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 |
| Anticipated start date | 01/10/2007 |
| Anticipated end date | 31/05/2014 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | Planned Sample Size: 4700; UK Sample Size: 250 |
| Interventions |
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/ |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-85214) |
| Trial website | http://www.ccc.mcmaster.ca/coronary.htm |
| Publications | |
| Contact name | Dr Andre Lamy |
| Address |
Hamilton General Hospital
237 Barton St. E. McMaster Clinic Room 704 |
| City/town | Hamilton, Ontario |
| Zip/Postcode | L8L 2X2 |
| Country | Canada |
| Tel | +1 905 522 0175 |
| Fax | +1 905 522 2029 |
| lamya@mcmaster.ca | |
| Sponsor | Population Health Research Institute (PHRI) (Canada) |
| Address |
McMaster University, General Site
237 Barton Street East |
| City/town | Hamilton, Ontario |
| Zip/Postcode | L8L 2X2 |
| Country | Canada |
| Sponsor website: | http://www.ccc.mcmaster.ca/ |
| Date applied | 04/02/2008 |
| Last edited | 31/08/2011 |
| Date ISRCTN assigned | 04/02/2008 |
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