Using Intraoperative Coronary Bypass Graft Imaging to Improve Graft Patency - Full Text View

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 III

MedlinePlus related topics:

Coronary Artery Bypass Surgery

ChemIDplus related topics:

Indocyanine green

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Official Title:	Graft Imaging to Improve Patency (GRIIP)

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 ]

Estimated Enrollment:	540
Study Start Date:	July 2005
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Graft patency assessment by routine clinical assessment with/without intraluminal coronary probe
2: Experimental 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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187421

Contacts


Contact: Randi Feder-Elituv, BSc	416-480-6100 ext 2451	randi.feder-elituv@suunybrook.ca

Locations


Canada, Ontario
	Division of Cardiovascular Surgery, Sunnybrook & Women's College Health Sciences Centre	Recruiting
	Toronto, Ontario, Canada, M4N 3M5
	Contact: Stephen E Fremes, MD,MSc,FRCSC 416-480-6073 stephen.fremes@sunnybrook.ca
	Contact: Randi Feder-Elituv, RN 416-480-6100 ext 2451 randi.feder-elituv@sunnybrook.ca
	Principal Investigator: Stephen E Fremes, MD,MSc,FRCSC

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

Responsible Party:	Sunnybrook Health Sciences Centre ( Stephen Fremes, Head Division of Cardiac and Vascular Surgery )
Study ID Numbers:	HSF NA 5530
First Received:	September 14, 2005
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00187421
Health Authority:	Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:

coronary disease

angiography

intraoperative care

vascular patency

Study placed in the following topic categories:

Coronary Disease

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Ischemia

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Sunnybrook Health Sciences Centre Heart and Stroke Foundation of Ontario
Information provided by:	Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00187421