The Cleveland Clinic Cardiothoracic Collaborative Clinical Center seeks to renew its participation in the Cardiothoracic Surgical Trials Network (CTSN). This Linked Clinical Research Center (LCRC) will consist of a primary site (Cleveland Clinic) linked with an affiliate site (Ochsner Clinic and Health System [Ochsner]) in New Orleans, LA, and a Clinical and Implementation Research Skills Program (CIRSP) to enrich the skills and knowledge of junior surgical investigators as they are trained to take on research roles in cardiothoracic surgery. As the largest-volume cardiac surgery program in the hemisphere, we propose to augment our clinical trial enrollment by leveraging the multiple disease-oriented centers within the Heart & Vascular Institute, which take the Heart Team model to a new level that includes within each center a mandate of research. Not only will we enroll patients into all clinical trials, but we will also lead Protocol Development Committees, draft manuscripts, and develop novel statistical methods as active participants in CTSN. We further suggest that we amplify the capacity of the Data Coordinating Center (DCC) by performing secondary analyses of trial data that will result in additional publications from each trial. We will further develop new statistical methods for more appropriate analysis of trial data. We propose also working with the DCC to write UG2/U24 grants for CTSN-proposed trials, thereby increasing the number of trials CTSN can conduct. Our affiliate, Ochsner, is in the Mississippi Delta that anchors the 11-state stroke, diabetes, obesity, hypertension, and heart disease belt. Following devastating Hurricane Katrina, it has just regained its cardiac surgery residency program, and has expanded from a single hospital into a Health System across the Gulf Coast. Although their cardiac surgeons have not participated in NIH-sponsored clinical trials, only industry-sponsored ones, they have sufficient infrastructure and desire to become a contributing member of the Network, thereby expanding its capacity and diversity. We will repurpose a successful Cleveland Clinic model for assessing, mentoring, and managing affiliate clinical programs across the US to enhance Ochsner?s clinical trials program. Cleveland Clinic is already involved in a 5-year contract with the National Diabetes and Obesity Research Institute to conquer diabetes along the Gulf Coast, with activities centered in Biloxi, MS. The program involves the governments of multiple states and a large number of stakeholders from community, industry, and academia. We will leverage this experience and that of our Cleveland CTSA and the NIH to amplify our educational program in T4 and Implementation Science. We will involve both our Cleveland Clinic Scholars and Ochsner Scholars in these new offerings, along with research opportunities in our existing MS and PhD programs.

Public Health Relevance

The Cardiothoracic Surgical Trials Network has conducted several clinically important randomized trials in heart valve disease, coronary artery disease, and heart failure, and has observed clinical practice related to infections following heart surgery. It is now embarking on a new paradigm whereby a well-established primary program will affiliate with a center located in an area of exceptionally high cardiovascular disease burden, with large numbers of people with diabetes, high blood pressure, obesity, and strokes. Further, it intends to expand into the area of implementation research, where it will identify strategies to bring proven therapies to clinical practice, thereby improving the treatment of patients with cardiovascular disease.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZHL1)
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Miller, Marissa A
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Cleveland Clinic Lerner
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