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

NCT01063491 | Unknown Phase 3 DMC

• 1 other identifier: 10-001
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.lower incidence major adverse cardiac events (death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and composite of death/myocardial infarction) (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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  12 months

• Major adverse cardiac events (death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and composite of death/myocardial infarction)

  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

  12 months

Study Arms (2)

Early graft angiography after coronary artery bypass surgery

EXPERIMENTAL

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

Procedure: bypass graft angiography

No early angiography after coronary artery bypass surgery

NO INTERVENTION

Interventions

bypass graft angiography PROCEDURE

Early graft angiography after coronary artery bypass surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead

Study Sites (1)

VA North Texas Healthcare System

Dallas, Texas, 75216, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Catheterization Laboratories

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

US (1)