Coronary Artery Bypass Graft SurgeryPhase 3CABG-PRONCT01063491
Cardiac CAtheterization for Bypass Graft Patency Rate Optimization: the CABG-PRO Randomized-controlled Pilot Study
A Phase 3 study testing bypass graft angiography in people with Coronary Artery Bypass Graft Surgery, run by North Texas Veterans Healthcare System at 1 site in United States.
Trial summary
Aortocoronary bypass graft failure is common and is associated with high morbidity and mortality. Failure of saphenous vein grafts is more common than failure of internal mammary artery grafts. Whether early graft angiography can reduce bypass graft failure remains unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery
- What is being tested?
- bypass graft angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
- Undergoing clinically-indicated coronary artery bypass graft surgery
Who cannot join
- Positive pregnancy test or breast-feeding
- Coexisting conditions that limit life expectancy to less than 12 months or that could affect a patient's compliance with the protocol
- Serum creatinine > 2.5 mg/dL or acute renal failure
- Severe peripheral arterial disease limiting vascular access
Trial locations and contacts
1 site in 1 country.
United States1 site
VA North Texas Healthcare System
Dallas, Texas, 75216
About this study
Aortocoronary bypass graft failure is common and is associated with high morbidity and mortality. Failure of saphenous vein grafts is more common than failure of internal mammary artery grafts. Whether early graft angiography can reduce bypass graft failure remains unknown. The Cardiac CAtheterization for Bypass Graft Patency Rate Optimization (CABG-PRO) randomized-controlled pilot study is a phase III, double-blind, randomized-controlled pilot trial that will randomize 170 patients undergoing coronary artery bypass graft surgery to early (before dismissal) graft angiography vs. no early graft angiography. Coronary angiography will be performed at 12 months, to determine whether compared to no early graft angiography, early graft angiography will result in:
- lower per patient angiographic bypass graft failure (in at least one graft) rates (defined as ≥75% diameter stenosis in at least one bypass graft) (primary efficacy endpoint)
- lower per graft failure rates, per graft occlusion rates, and per patient bypass graft occlusion rates (in at least one bypass graft) (secondary endpoints)
- lower incidence major adverse cardiac events (death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and composite of death/myocardial infarction) (secondary endpoint)
Intravascular ultrasonography and near-infrared spectroscopy will also be performed in at least one bypass graft at baseline (in the early graft angiography group only) and at 12-month angiographic follow-up to evaluate the structural bypass graft changes occurring after coronary artery bypass graft surgery (secondary endpoint).
- Conditions
- Coronary Artery Bypass Graft Surgery
- Being tested
- bypass graft angiography
- Keywords
- coronary artery bypass graft surgery, bypass grafts, angiography, percutaneous coronary intervention, coronary imaging, coronary artery bypass graft surgery, bypass graft patency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bypass graft angiographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Early graft angiography after coronary artery bypass surgery | Experimental | Treatment of any bypass graft abnormalities that are discovered will be performed if needed Receives: Procedure: bypass graft angiography |
| No early angiography after coronary artery bypass surgery | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per patient bypass graft failure (defined as ≥75% graft diameter stenosis) in at least one bypass graft, as assessed by quantitative coronary angiography performed at 12 months.
Measured: 12 months
Secondary outcomes (3)
Per graft incidence of bypass graft failure; per graft incidence of bypass graft occlusion; and per patient incidence of at least one bypass graft occlusion
Measured: 12 months
Major adverse cardiac events (death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and composite of death/myocardial infarction)
Measured: 12 months
Mean SVG lumen diameter and wall thickness, as assessed by intravascular ultrasonography and mean lipid core burden index, as assessed by near-infrared intracoronary spectroscopy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Emmanouil Brilakis, North Texas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063491
- Sponsor's protocol ID
- 10-001
- Acronym
- CABG-PRO
- Status last verified
- Oct 2013
- First submitted
- 4 Feb 2010
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac CAtheterization for Bypass Graft Patency Rate Optimization: the CABG-PRO Randomized-controlled Pilot Study
- ClinicalTrials.gov ID
- NCT01063491
- Acronym / sponsor ID
- CABG-PRO / 10-001
- Conditions
- Coronary Artery Bypass Graft Surgery
- Keywords
- coronary artery bypass graft surgery, bypass grafts, angiography, percutaneous coronary intervention, coronary imaging, coronary artery bypass graft surgery, bypass graft patency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Study start
- Feb 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 5 Feb 2010 (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.
Aortocoronary bypass graft failure is common and is associated with high morbidity and mortality. Failure of saphenous vein grafts is more common than failure of internal mammary artery grafts. Whether early graft angiography can reduce bypass graft failure remains unknown. The Cardiac CAtheterization for Bypass Graft Patency Rate Optimization (CABG-PRO) randomized-controlled pilot study is a phase III, double-blind, randomized-controlled pilot trial that will randomize 170 patients undergoing coronary artery bypass graft surgery to early (before dismissal) graft angiography vs. no early graft angiography. Coronary angiography will be performed at 12 months, to determine whether compared to no early graft angiography, early graft angiography will result in:
- lower per patient angiographic bypass graft failure (in at least one graft) rates (defined as ≥75% diameter stenosis in at least one bypass graft) (primary efficacy endpoint)
- lower per graft failure rates, per graft occlusion rates, and per patient bypass graft occlusion rates (in at least one bypass graft) (secondary endpoints)
- lower incidence major adverse cardiac events (death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and composite of death/myocardial infarction) (secondary endpoint)
Intravascular ultrasonography and near-infrared spectroscopy will also be performed in at least one bypass graft at baseline (in the early graft angiography group only) and at 12-month angiographic follow-up to evaluate the structural bypass graft changes occurring after coronary artery bypass graft surgery (secondary endpoint).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early graft angiography after coronary artery bypass surgery | Experimental | Procedure: bypass graft angiographyTreatment of any bypass graft abnormalities that are discovered will be performed if needed |
| No early angiography after coronary artery bypass surgery | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
- Undergoing clinically-indicated coronary artery bypass graft surgery
Key exclusion criteria (4 listed)
- Positive pregnancy test or breast-feeding
- Coexisting conditions that limit life expectancy to less than 12 months or that could affect a patient's compliance with the protocol
- Serum creatinine > 2.5 mg/dL or acute renal failure
- Severe peripheral arterial disease limiting vascular access
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 |
|---|---|---|
| bypass graft angiography | Procedure or surgery | Early graft angiography after coronary artery bypass surgery |
Primary outcome
Per patient bypass graft failure (defined as ≥75% graft diameter stenosis) in at least one bypass graft, as assessed by quantitative coronary angiography performed at 12 months.
Time frame: 12 months
3 secondary outcomes
Per graft incidence of bypass graft failure; per graft incidence of bypass graft occlusion; and per patient incidence of at least one bypass graft occlusion
Time frame: 12 months
Major adverse cardiac events (death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and composite of death/myocardial infarction)
Time frame: 12 months
Mean SVG lumen diameter and wall thickness, as assessed by intravascular ultrasonography and mean lipid core burden index, as assessed by near-infrared intracoronary spectroscopy
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 bypass graft angiography in people with Coronary Artery Bypass Graft Surgery, run by North Texas Veterans Healthcare System at 1 site in United States.
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 4 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: status not confirmed, as of the sponsor's last update on 1 Nov 2013. 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 United States. 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?
Results are not available in the source record.
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?
Per patient bypass graft failure (defined as ≥75% graft diameter stenosis) in at least one bypass graft, as assessed by quantitative coronary angiography performed at 12 months. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2013; AzTrials last refreshed its copy on 4 Nov 2026.