The Cardiothoracic Surgical Trials Network (CTSN) seeks to develop and execute clinical trials to evaluate the efficacy of new cardiac surgeries/management protocols and the effectiveness of existing ones, requiring successful patient recruitment and retention. Baylor Research Institute and the Cardiopulmonary Research Science and Technology Institute formed a consortium (BRI-CRSTI) consisting of 2 research institutes and the 3 largest cardiac surgery programs in the Dallas-Fort Worth region (DFW), has demonstrated such success and is ideally positioned to be a CTSN Core Center, with the potential to become one of the highest enrolling Core Centers. BRI-CRSTI is a CTSN Satellite Site, is participating in 144 active trials, and has published >650 peer-reviewed articles. Examples of our clinical trial success include enrolling: 1) 155 patients, Edwards Lifesciences Pivotal PARTNER Trial (3rd highest site);2) 60 patients, SYNTAX: Trial of left main and 3 vessel disease (highest U.S. site);3) 22 patients, CTSN Trials for moderate mitral regurgitation, severe mitral regurgitation, atrial fibrillation (AF) (5th, 3rd, and highest satellite sites respecively) and left ventricular assist device (LVAD) current high enroller);and 4) 4 patients to date in Medtronic's SYMPLICITY Trial (2nd highest site). Key to our success is our research infrastructure, particularly the multidisciplinary heart clinics, in which surgeons, cardiologists, staff and research coordinators meet bi-weekly to screen all patients (~25 per week) with aortic/mitral valve disease or AF for study eligibility. BRI-CRSTI is also experienced with observational registries, participating in the coronary artery disease CARE Registry, the LVAD NIH INTERMACS Registry, the Ascending Aortic Aneurysm registry (>7,000 patients), and the prospective AFIB registry (40,000 patients undergoing surgery for AF), as well as the STS National Adult Cardiac Surgery Database. Most recently, BRI-CRSTI, collaborating with the Dallas Fort Worth Hospital Council and 32 DFW hospitals, formed the Texas Quality Initiative (TQI) to improve patient outcomes. TQI will merge clinical data from the STS Database with hospitals'administrative and financial data for long-term outcomes research and to develop and evaluate the impact of innovative cardiovascular care pathways.

Public Health Relevance

Each year, 3 million patients worldwide and 800,000 patients in the U.S. undergo cardiac surgery. BRI-CRSTI offers a unique clinical trial and outcomes research model in addition to a large cardiac surgery patient population, positioning it to be a highly valuable CTSN Core Center, meaningfully contributing to CTSN's evaluation of the efficacy and effectiveness of cardiac surgeries/management protocols, ultimately improving patient care and outcomes.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
5UM1HL117922-02
Application #
8711553
Study Section
Special Emphasis Panel (ZHL1-CSR-H (F1))
Program Officer
Miller, Marissa A
Project Start
2013-08-01
Project End
2018-01-31
Budget Start
2014-02-01
Budget End
2015-01-31
Support Year
2
Fiscal Year
2014
Total Cost
$349,316
Indirect Cost
$126,538
Name
Baylor Research Institute
Department
Type
DUNS #
145745022
City
Dallas
State
TX
Country
United States
Zip Code
75204