|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| 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:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
|
||||
| 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 † |
|
||||
| Information Provided By | Sunnybrook Health Sciences Centre | ||||
| Verification Date | May 2008 | ||||
| First Received Date † | September 14, 2005 | ||||
| Last Updated Date | May 22, 2008 | ||||