Using Intraoperative Coronary Bypass Graft Imaging to Improve Graft Patency

Coronary Disease Clinical Trial

— GRIIP  

Official title:

Graft Imaging to Improve Patency (GRIIP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00187421
• Other study ID #: HSF NA 5530
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: December 11, 2012
• Start date: July 2005
• Est. completion date: August 2009

Study information

• Verified date: December 2012
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Procedure:
• Indocyanine green intraoperative angiogram and transit-time flowmetry
ICG graft angiography following each distal anastomosis, and imaging of proximal anastomoses after all grafts completed. transit time flowmetry performed on all grafts after all grafts completed.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft occlusion determined by conventional angiography or CT angiography		4 days to 4 months following surgery	No
Secondary	50-99% graft stenosis on postoperative graft angiography		4 day to 4 months postoperatively	No
Secondary	Mortality, myocardial infarction, low output syndrome		Perioperatively	No
Secondary	Major cardiac adverse events		1 year postoperatively	No