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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01063491
First received: February 4, 2010
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention Phase
Coronary Artery Bypass Graft Surgery
Procedure: bypass graft angiography
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiac CAtheterization for Bypass Graft Patency Rate Optimization: the CABG-PRO Randomized-controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Major adverse cardiac events (death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, and composite of death/myocardial infarction) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: February 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early graft angiography after coronary artery bypass surgery
Treatment of any bypass graft abnormalities that are discovered will be performed if needed
Procedure: bypass graft angiography
No Intervention: No early angiography after coronary artery bypass surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063491

Locations
United States, Texas
VA North Texas Healthcare System
Dallas, Texas, United States, 75216
Sponsors and Collaborators
North Texas Veterans Healthcare System
  More Information

No publications provided

Responsible Party: Emmanouil Brilakis, Director, Cardiac Catheterization Laboratories, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT01063491     History of Changes
Other Study ID Numbers: 10-001
Study First Received: February 4, 2010
Last Updated: October 31, 2013
Health Authority: United States: Federal Government

Keywords provided by North Texas Veterans Healthcare System:
coronary artery bypass graft surgery
bypass grafts
angiography
percutaneous coronary intervention
coronary imaging
coronary artery bypass graft surgery, bypass graft patency

ClinicalTrials.gov processed this record on July 22, 2014