Coronary DiseasePhase 3GRIIPNCT00187421
Using Intraoperative Coronary Bypass Graft Imaging to Improve Graft Patency
A Phase 3 study testing Indocyanine green intraoperative angiogram and transit-time flowmetry in people with Coronary Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Indocyanine green intraoperative angiogram and transit-time flowmetry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2005to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- isolated aortocoronary bypass surgery
- left ventricular ejection fraction >20%
- expect at least 2 bypass grafts
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Disease
- Being tested
- Indocyanine green intraoperative angiogram and transit-time flowmetry
- Keywords
- coronary disease, angiography, intraoperative care, vascular patency
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green intraoperative angiogram and transit-time flowmetryProcedure or surgery
Also called Novadaq Spy System, Medtronic Medistem
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Indocyanine green intraoperative angiogram and transit-time flowmetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft occlusion determined by conventional angiography or CT angiography
Measured: 4 days to 4 months following surgery
Secondary outcomes (3)
50-99% graft stenosis on postoperative graft angiography
Measured: 4 day to 4 months postoperatively
Mortality, myocardial infarction, low output syndrome
Measured: Perioperatively
Major cardiac adverse events
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Responsible party
- Principal investigator, Stephen E. Fremes, Sunnybrook Health Sciences Centre
- Investigators
- Stephen E Fremes, MD,MSc,FRCSC, Principal investigator, Division of Cardiac and Vascular Surgery, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187421
- Sponsor's protocol ID
- HSF NA 5530
- Acronym
- GRIIP
- Status last verified
- Dec 2012
- First submitted
- 14 Sep 2005
- Last updated
- 12 Dec 2012
- Results posted
- No
Publications
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.
PubMed 20006356
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graft Imaging to Improve Patency (GRIIP)
- ClinicalTrials.gov ID
- NCT00187421
- Acronym / sponsor ID
- GRIIP / HSF NA 5530
- Conditions
- Coronary Disease
- Keywords
- coronary disease, angiography, intraoperative care, vascular patency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Jul 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Graft patency assessment by routine clinical assessment with/without intraluminal coronary probe |
| 2 | Experimental | Procedure: Indocyanine green intraoperative angiogram and transit-time flowmetryGraft patency assessment by indocyanine green angiography and transit-time flowmetry |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- isolated aortocoronary bypass surgery
- left ventricular ejection fraction >20%
- expect at least 2 bypass grafts
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine green intraoperative angiogram and transit-time flowmetryAlso: Novadaq Spy System, Medtronic MedistemICG 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. | Procedure or surgery | 2 |
Primary outcome
Graft occlusion determined by conventional angiography or CT angiography
Time frame: 4 days to 4 months following surgery
3 secondary outcomes
50-99% graft stenosis on postoperative graft angiography
Time frame: 4 day to 4 months postoperatively
Mortality, myocardial infarction, low output syndrome
Time frame: Perioperatively
Major cardiac adverse events
Time frame: 1 year postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2012.
- Results publication: PubMed 20006356Singh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen E Fremes, MD,MSc,FRCSC principal investigator
Division of Cardiac and Vascular Surgery, Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indocyanine green intraoperative angiogram and transit-time flowmetry in people with Coronary Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft occlusion determined by conventional angiography or CT angiography (time frame: 4 days to 4 months following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00187421, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2012.