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

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Stephen E. Fremes, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00187421
First received: September 14, 2005
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Coronary Disease
Procedure: Indocyanine green intraoperative angiogram and transit-time flowmetry
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Graft Imaging to Improve Patency (GRIIP)

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment: 156
Study Start Date: July 2005
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Graft patency assessment by routine clinical assessment with/without intraluminal coronary probe
Experimental: 2
Graft patency assessment by indocyanine green angiography and transit-time flowmetry
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.

Other Names:
  • Novadaq Spy System
  • Medtronic Medistem

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00187421

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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
  More Information

Publications:
Responsible Party: Stephen E. Fremes, Head , Division of Cardiac Surgery, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00187421     History of Changes
Other Study ID Numbers: HSF NA 5530
Study First Received: September 14, 2005
Last Updated: December 11, 2012
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
coronary disease
angiography
intraoperative care
vascular patency

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014