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

December 11, 2012 updated by: Stephen E. Fremes, Sunnybrook Health Sciences Centre

Graft Imaging to Improve Patency (GRIIP)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Graft occlusion determined by conventional angiography or CT angiography
Time Frame: 4 days to 4 months following surgery
4 days to 4 months following surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
50-99% graft stenosis on postoperative graft angiography
Time Frame: 4 day to 4 months postoperatively
4 day to 4 months postoperatively
Mortality, myocardial infarction, low output syndrome
Time Frame: Perioperatively
Perioperatively
Major cardiac adverse events
Time Frame: 1 year postoperatively
1 year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

December 12, 2012

Last Update Submitted That Met QC Criteria

December 11, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSF NA 5530

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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