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Multicentre Radial Artery Patency Study: 5 Year Results

This study is currently recruiting participants.
Verified by Sunnybrook Health Sciences Centre, February 2006

Sponsors and Collaborators: Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
Information provided by: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00187356
  Purpose

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   

U.S. FDA Resources

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

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • The primary endpoint will be the proportion of grafts which are functionally occluded (TIMI flow 0, 1, or 2).

Secondary Outcome Measures:
  • a) the proportion of occluded study grafts (TIMI 0)
  • b) the proportion of functionally patent TIMI 3 study grafts which are significantly diseased by quantitative angiography
  • c) proportion of diseased and occluded grafts

Estimated Enrollment:   350
Study Start Date:   July 2002
Estimated Study Completion Date:   July 2007

Detailed Description:

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

  1. The angiographic patency of radial artery grafts studied 5 years following surgery exceeds that of saphenous vein grafts.
  2. Radial artery conduits studied 5 years postoperatively have less graft disease than saphenous veins.

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.

  Eligibility
Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187356

Contacts
Contact: Stephen E Fremes, MD     416-480-6073    

Locations
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            

Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)

Investigators
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    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Other Publications:

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

Keywords provided by Sunnybrook Health Sciences Centre:
Coronary Bypass Surgery  
Coronary Artery Disease  
Angiography  
Arterial Grafts
Radial Artery
Saphenous Vein

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 24, 2008




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