Clinical trial NCT00187421: Using Intraoperative Coronary Bypass Graft Imaging to Improve Graft Patency
Official title: Graft Imaging to Improve Patency (GRIIP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Disease
Keywords: coronary disease
angiography
intraoperative care
vascular patency
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2005-09-16
Enrollment: 156
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Graft occlusion determined by conventional angiography or CT angiography
timeFrame: 4 days to 4 months following surgery
Secondary outcomes:
measure: 50-99% graft stenosis on postoperative graft angiography
timeFrame: 4 day to 4 months postoperatively
measure: Mortality, myocardial infarction, low output syndrome
timeFrame: Perioperatively
measure: Major cardiac adverse events
timeFrame: 1 year postoperatively
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Division of Cardiac and Vascular Surgery, Sunnybrook Health Sciences Centre
name: Stephen E Fremes, MD,MSc,FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh SK, Desai ND, Chikazawa G, Tsuneyoshi H, Vincent J, Zagorski BM, Pen V, Moussa F, Cohen GN, Christakis GT, Fremes SE. The Graft Imaging to Improve Patency (GRIIP) clinical trial results. J Thorac Cardiovasc Surg. 2010 Feb;139(2):294-301, 301.e1. doi: 10.1016/j.jtcvs.2009.09.048. Epub 2009 Dec 16.