Cardiac CAtheterization for Bypass Graft Patency Rate Optimization: the CABG-PRO Randomized-controlled Pilot Study

NCT ID: NCT01063491

Last Updated: 2013-11-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-12-31

Brief 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. 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:

1. 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)

2. lower per graft failure rates, per graft occlusion rates, and per patient bypass graft occlusion rates (in at least one bypass graft) (secondary endpoints)

3. 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

Keywords

coronary artery bypass graft surgery; bypass grafts; angiography; percutaneous coronary intervention; coronary imaging; coronary artery bypass graft surgery, bypass graft patency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early graft angiography after coronary artery bypass surgery

Treatment of any bypass graft abnormalities that are discovered will be performed if needed

Group Type: EXPERIMENTAL

bypass graft angiography

Intervention Type: PROCEDURE

No early angiography after coronary artery bypass surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

bypass graft angiography

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age >18 years

2. Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.

3. Undergoing clinically-indicated coronary artery bypass graft surgery

Exclusion Criteria

1. Positive pregnancy test or breast-feeding

2. Coexisting conditions that limit life expectancy to less than 12 months or that could affect a patient's compliance with the protocol

3. Serum creatinine > 2.5 mg/dL or acute renal failure

4. Severe peripheral arterial disease limiting vascular access

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North Texas Veterans Healthcare System

FED

Sponsor Role: lead

Responsible Party

Emmanouil Brilakis

Director, Cardiac Catheterization Laboratories

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VA North Texas Healthcare System

Dallas, Texas, United States

Countries

United States

Other Identifiers

10-001

Identifier Type: -

Identifier Source: org_study_id