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

Coronary Artery Bypass Graft Surgery Clinical Trial

— CABG-PRO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01063491
• Other study ID #: 10-001
• Status: Active, not recruiting
• Phase: Phase 3
• First received: February 4, 2010
• Last updated: October 31, 2013
• Start date: February 2010
• Est. completion date: December 2013

Study information

• Verified date: October 2013
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 170
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass Graft Surgery

Intervention

Procedure:
• bypass graft angiography

Locations

Country	Name	City	State
United States	VA North Texas Healthcare System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Major adverse cardiac events (death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and composite of death/myocardial infarction)		12 months	Yes
Secondary	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	No