NCT00187421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

December 12, 2012

Status Verified

December 1, 2012

Enrollment Period

4.1 years

First QC Date

September 14, 2005

Last Update Submit

December 11, 2012

Conditions

Coronary Disease

Keywords

coronary diseaseangiographyintraoperative carevascular patency

Outcome Measures

Primary Outcomes (1)

  • Graft occlusion determined by conventional angiography or CT angiography

    4 days to 4 months following surgery

Secondary Outcomes (3)

  • 50-99% graft stenosis on postoperative graft angiography

    4 day to 4 months postoperatively

  • Mortality, myocardial infarction, low output syndrome

    Perioperatively

  • Major cardiac adverse events

    1 year postoperatively

Study Arms (2)

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

Interventions

Indocyanine green intraoperative angiogram and transit-time flowmetryPROCEDURE

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.

Also known as: Novadaq Spy System, Medtronic Medistem
2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • isolated aortocoronary bypass surgery
  • left ventricular ejection fraction \>20%
  • expect at least 2 bypass grafts

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related 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: 10.1016/j.jtcvs.2009.09.048. Epub 2009 Dec 16.

    PMID: 20006356RESULT

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Stephen E Fremes, MD,MSc,FRCSC

    Division of Cardiac and Vascular Surgery, Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head , Division of Cardiac Surgery

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

July 1, 2005

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

December 12, 2012

Record last verified: 2012-12

Locations

CA(1)