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Using Intraoperative Coronary Bypass Graft Imaging to Improve Graft Patency (GRIIP)

This study is currently recruiting participants.
Study NCT00187421.   Last updated on May 22, 2008.   Information provided by Sunnybrook Health Sciences Centre

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Descriptive Information Fields
Brief Title  Using Intraoperative Coronary Bypass Graft Imaging to Improve Graft Patency
Official Title  Graft Imaging to Improve Patency (GRIIP)
Brief Summary

The primary objective of the proposed study is to determine if a strategy of intraoperative patency assessment and graft revision can decrease the rate of graft occlusion or significant stenosis (>50%) at 6-12 weeks after coronary artery bypass grafting (CABG) versus traditional operative management without routine intraoperative patency assessment. Patency will be assessed with a new fluorescence angiography technique as well as ultrasonic transit-time flow measurement. We hypothesize that the strategy of intraoperative patency assessment and graft revision will significantly reduce the frequency of graft occlusion at 6-12 weeks in comparison to patients who do not have intraoperative patency assessment. We also hypothesize that the strategy of intraoperative patency assessment and graft revision will significantly reduce the frequency of 50-99% stenoses at 6-12 weeks in comparison to patients who do not have intraoperative patency assessment. We expect both groups will experience similar perioperative outcomes but hypothesize that patients receiving a strategy of intraoperative patency assessment and graft revision will experience improved long-term graft patency and freedom from late clinical events at 5-6 years post-operatively.

Detailed Description

The immediate and long term success of coronary surgery is dependent on the construction of a high quality anastomosis with a durable conduit to an appropriate target coronary vessel. Significant advances in medical therapy including early post-operative aspirin administration and increased use of arterial grafting have improved early, midterm and late graft patency. However, modern coronary bypass series continue to report perioperative graft occlusions rates as high as 11%. These very early graft failures have been predominantly ascribed to technical problems at graft anastomosis sites and may be preventable. New intraoperative graft assessment technologies have recently become available which can identify technical problems such that they can be repaired in the operating room. However, these techniques increase the length of the bypass operation and may have false positives, which may lead to unnecessary and potentially damaging graft revisions. The primary objective of the proposed study is to determine if a strategy of intraoperative patency assessment and graft revision can decrease the rate of graft occlusion or significant stenosis(>50%) at 6-12 weeks after coronary artery bypass grafting (CABG) versus traditional operative management without routine intraoperative patency assessment.

Study Phase Phase III
Study Type  Interventional
Study Design  Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Graft occlusion determined by conventional angiography or CT angiography [ Time Frame: 4 days to 4 months following surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measure  50-99% graft stenosis on postoperative graft angiography [ Time Frame: 4 day to 4 months postoperatively ] [ Designated as safety issue: No ]
Mortality, myocardial infarction, low output syndrome [ Time Frame: Perioperatively ] [ Designated as safety issue: No ]
Major cardiac adverse events [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: No ]
Condition  Coronary Disease
Intervention  Procedure: Indocyanine green intraoperative angiogram and transit-time flowmetry
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  540
Start Date  July 2005
Completion Date June 2009
Eligibility Criteria 

Inclusion Criteria:

  • isolated aortocoronary bypass surgery
  • left ventricular ejection fraction >20%
  • expect at least 2 bypass grafts

Exclusion Criteria:

  • renal insufficiency (creatinine >180 umol/L)
  • known allergy to indocyanine green contrast dye
  • severe peripheral vascular disease precluding femoral access
  • known allergy to radiographic contrast media
  • women of childbearing potential
  • co-morbid illness which precludes the use of follow-up angiography
  • geographically inaccessible for follow-up angiography
Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Contact: Randi Feder-Elituv, BSc     416-480-6100 ext 2451     randi.feder-elituv@suunybrook.ca    
Location Countries  Canada
Administrative Information Fields
NCT ID  NCT00187421
Organization ID HSF NA 5530
Secondary IDs ††
Study Sponsor  Sunnybrook Health Sciences Centre
Collaborators †† Heart and Stroke Foundation of Ontario
Investigators 
Principal Investigator:     Stephen E Fremes, MD,MSc,FRCSC     Division of Cardiac and Vascular Surgery, Sunnybrook Health Sciences Centre    
Information Provided By Sunnybrook Health Sciences Centre
Verification Date May 2008
First Received Date  September 14, 2005
Last Updated Date May 22, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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