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Sponsors and Collaborators: |
Sunnybrook Health Sciences Centre Canadian Institutes of Health Research (CIHR) |
Information provided by: | Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT00187356 |
Bypass surgery is often required to treat severe coronary heart disease. Either arteries or veins can be used as bypass grafts. We wish to compare the long-term durability of the saphenous vein from the leg to that of the radial artery from the fore-arm when used as bypass grafts. We are examining how many of these grafts are still functioning at 5 years by performing a coronary angiogram. After 1-year, we found that radial arteries were more likely to be functioning than saphenous veins. We hypothesize that radial arteries will continue to be superior at 5 years.
Condition | Intervention | Phase |
Coronary Artery Disease |
Procedure: Radial Artery and Saphenous Vein Grafts Randomized to either right coronary or left circumflex coronary artery territories |
Phase III |
MedlinePlus related topics: | Coronary Artery Disease |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Multicentre Radial Artery Patency Study: 5 Year Results |
Estimated Enrollment: | 350 |
Study Start Date: | July 2002 |
Estimated Study Completion Date: | July 2007 |
The multi-centre Radial Artery Patency Study, (RAPS) is a series of longitudinal graft patency studies designed to compare the long-term patency of the radial artery to the saphenous vein. Between 1996 and 2001, 561 patients were intraoperatively randomized to undergo surgery according to one of two strategies: radial-artery grafting to the circumflex territory and saphenous-vein grafting to the right coronary artery or radial-artery grafting to the right coronary artery and saphenous-vein grafting to the circumflex territory. The first study compared the 8-12 month angiographic patency of the radial artery with that of the saphenous vein as a conduit for coronary artery bypass and found that radial arteries were superior. The primary objective of this current study is to determine the 5-year angiographic patency of the radial artery compared with a saphenous vein coronary bypass graft.
HYPOTHESES
SAMPLE SIZE We expect to study 350 patients, which will allow us to test for a 35% risk reduction from 23% occlusion rate in saphenous veins to 15% in radial arteries, assuming a 5% within-patient correlation, with 80% power for a 2-tailed alpha of 0.05.
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The patient population consists of patients who were enroled into the original Multicentre Radial Artery Patency Study between November 1996 and January 2001. These included patients undergoing isolated coronary artery bypass surgery less than 80 years of age with 3 vessel coronary disease and left ventricular ejection fraction greater than 35%.
Exclusion Criteria:
Exclusion criteria included 1: Inability to use the radial artery or saphenous vein conduits: a)nonpalpable ulnar arteries or a positive Allen’s test, b) an abnormal Doppler study or ultrasonographic study of the arms, c) a history of vasculitis or Raynaud’s syndrome, bilateral varicose veins or vein stripping. 2: Conditions that affected the safety of follow-up angiography: a)renal insufficiency (creatinine > 180 umol/L) b)severe peripheral vascular disease precluding femoral access b)coagulopathy or obligatory uninterrupted use of anticoagulants c) known allergy to radiographic contrast media d) women of childbearing potential e) comorbid illness which precludes the use of follow up angiography f) geographically inaccessible for follow up angiography.
Contact: Stephen E Fremes, MD | 416-480-6073 |
Canada, Alberta | |||||
University of Alberta | Recruiting | ||||
Edmonton, Alberta, Canada, T6G 2B7 | |||||
Contact: Mary-Ann James mjames@cha.ab.ca | |||||
Principal Investigator: Elliott Gelfand, MD | |||||
Canada, Manitoba | |||||
Manitoba Health Sciences Centre | Recruiting | ||||
Winnipeg, Manitoba, Canada, R3A 1R9 | |||||
Contact: Angie Munoz munoz@hsc.mb.ca | |||||
Principal Investigator: Michael Raabe | |||||
Canada, Ontario | |||||
Sunnybrook and Women's College HSC | Recruiting | ||||
Toronto, Ontario, Canada, M4N3M5 | |||||
Contact: Nimesh D Desai, MD 416-480-6073 nimesh.desai@utoronto.ca | |||||
Principal Investigator: Stephen E Fremes, MD | |||||
Ottawa Heart Institute | Recruiting | ||||
Ottawa, Ontario, Canada, K1Y 4W7 | |||||
Contact: Sharon Finlay sharon.finly@ottawaheart.ca | |||||
Principal Investigator: Fraser D Rubens, MD | |||||
St. Michael's Hospital | Recruiting | ||||
Toronto, Ontario, Canada, M5B1W8 | |||||
Contact: Mary Keith, MD 416-8646060 ext 4008 keith@smh.toronto.on.ca | |||||
Principal Investigator: Lee Errett, MD | |||||
Toronto General Hospital | Recruiting | ||||
Toronto, Ontario, Canada, M5G2C4 | |||||
Contact: Chet Nacario 4163404800 ext 8435 chet.nacario@uhn.on.ca | |||||
Principal Investigator: Terry Yau, MD | |||||
London Health Sciences Centre - UC | Recruiting | ||||
London, Ontario, Canada, N6A 5A5 | |||||
Contact: Stephanie Fox (519)685-8500 ext 35051 | |||||
Principal Investigator: Richard Novick | |||||
London Health Sciences Centre - VC | Recruiting | ||||
London, Ontario, Canada, N6B1B1 | |||||
Contact: Stephanie Fox (519)685-8500 ext 35031 | |||||
Principal Investigator: Mary L Myers, MD | |||||
Vancouver General Hospital | Recruiting | ||||
Vancouver, Ontario, Canada, V5Z1C6 | |||||
Contact: Neetha Hsu cardres@interchange.ubc.ca | |||||
Principal Investigator: Guy Fradet, MD | |||||
Canada, Quebec | |||||
Montreal Heart Institute | Recruiting | ||||
Montreal, Quebec, Canada, H1T 1C8 | |||||
Contact: Raymond Cartier, MD 1 514 593-2511 rc2910@aol.com | |||||
Principal Investigator: Raymond Cartier, MD | |||||
Montreal Jewish General Hospital | Recruiting | ||||
Montreal, Quebec, Canada, H3T 1E2 | |||||
Contact: Maggie Crecca 514-340-8222 ext 3844 mcrecca@primus.ca | |||||
Principal Investigator: JF Morin, MD | |||||
Laval Hospital | Recruiting | ||||
Laval, Quebec, Canada, G1V4G5 | |||||
Contact: Brigette Dionne Brigitte.Dionne@crhl.ulaval.ca | |||||
Principal Investigator: Daniel Doyle, MD | |||||
New Zealand | |||||
Waikato Hospital | Recruiting | ||||
Hamilton, New Zealand | |||||
Contact: Diane Penny diane.penny@waikato.nz | |||||
Principal Investigator: Ravi Ullal, MD |
Sunnybrook Health Sciences Centre |
Canadian Institutes of Health Research (CIHR) |
Study Chair: | Stephen E Fremes, MD | Sunnybrook and Women's College HSC |
Principal Investigator: | Nimesh D Desai, MD | Sunnybrook and Women's HSC |
Principal Investigator: | Eric A Cohen, MD | Sunnybrook and Women's HSC |
Related Info 
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Study ID Numbers: | CIHR MCT# 52681 |
First Received: | September 10, 2005 |
Last Updated: | February 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00187356 |
Health Authority: | Canada: Ethics Review Committee |
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