The Bypass Angioplasty Revascularization Investigation (BARI) is a randomized clinical trial comparing an initial strategy of PTCA versus CABG at 19 clinical sites. Duke University Medical Center has contributed data of exceptional quality and maintained an excellent compliance record throughout the trial. Duke screened 2308 patients with multivessel disease and randomized 129 patients, placing 207 in the registry subgroup and 54 in the angiographically excluded registry. Of these participants, 30% are female and 7% are African American. Timeliness of data submission and protocol adherence on thee patients have been outstanding. Duke's data submission to the Central Radiographic Laboratory has consistently been among the top three centers participating in the trial. Electrocardiograms acquisition rates to the Core ECG Laboratory have continually been in the 90 percent range. Mechanisms have been instituted to ensure and improve these compliance rates in the future. Our staff has been stable throughout the trial and we attribute our high patient compliance in all aspects of the trial to this continuity. We do not anticipate changes to the personnel in the future. The work of the BARI team at Duke has improved the continuity of patient care, strengthened the working relationship within the medical center and augmented collaborative care with local physicians. Duke has contributed significantly to the success of various important substudies within BARI. Duke Medical Center and the staff involved in BARI are prepared to uphold their commitment to quality data collection and compliance submission if follow-up is extended. Duke has initiated the necessary mechanisms to insure a continued high rate of patient compliance and quality data collection. The strength of the overall study lies in the ability of the sites to accurately reflect all aspects of the course of coronary revascularization procedures. These results will have a significant impact on the future treatment of coronary artery disease.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01HL038516-09
Application #
2218895
Study Section
Clinical Trials Review Committee (CLTR)
Project Start
1987-06-01
Project End
1997-11-30
Budget Start
1994-12-01
Budget End
1995-11-30
Support Year
9
Fiscal Year
1995
Total Cost
Indirect Cost
Name
Duke University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
071723621
City
Durham
State
NC
Country
United States
Zip Code
27705