Project Summary This proposal documents the significant contributions that the University of Virginia (UVA) has made to the NIHLBI/ NINDS sponsored Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine as one of eight core sites. These important contributions have spanned from leading and participating in numerous protocol development committees, consistently being one of the top enrollers in CTSN trials, and successfully functioning as one of 3 Skills Development Programs in the network. UVA performs 1100-1200 adult cardiac procedures annually which are available for recruitment in clinical research as the highest institutional priority. The UVA investigative group is led by Dr. Gorav Ailawadi, the Chief of Cardiac Surgery and an active cardiac surgeon, who has been active in the Network for 10 years with a number of committee and leadership roles. Dr. Ailawadi also has leadership roles in the Virginia Cardiac Services Quality Initiative designed to improve cardiac care in Virginia, a successful model for implementation science. The UVA team has been highly committed with strong collaboration among surgeons, cardiologists, and neurologists evidence by consistent top enrollment in nearly every CTSN trial. UVA will function as the experienced network site in this proposal and will partner with less experienced site in West Virginia University (WVU) who proudly cared for a large underserved population with a reputation for high quality clinical care. Recently, great investments have been made to develop the WVU Heart and Vascular Institute, led by Dr. Vinay Badhwar, as an integrated service line model combining cardiac surgery and cardiology under a single leader. Dr. Badhwar is a renowned cardiac surgeon with national leadership roles in our major societies as well as strong relationships with industry. He has recruited several top notch surgeons, cardiologists, and imagers with excellent track records in clinical trials and high quality care. Moreover, the recent reorganization at WVU has resulted in a significant investment in research funds and infrastructure. Collectively, these investments make WVU an ideal site to join the Network, with ability and capacity to contribute highly to patient enrollment and trial designs. Further, our sites serve unique underserved patients with high cardiovascular disease burden, who travel from great distances to receive their care. Our specific aims focus on three areas: 1) To optimize participation and utilize novel and innovative approaches for the recruitment and retention of patients in CTSN trials among our two institutions. 2) To mentor and build capacity for WVU as a new affiliate site in a rapid fashion allowing immediate contributions to the Network. 3) To support the development of clinical and implementation skills broadly across trainees and mentees across our institutions to develop future leaders in clinical research in cardiac care.

Project Narrative The University of Virginia (UVA) and West Virginia University (WVU) are partnering to form a Linked Clinical Research Center to conduct heart and vascular clinical research trials with the goal of serving the vulnerable Appalachian community. This partnership has been designed to increase the capability of WVU to conduct clinical research trials using UVA’s excellent experience in heart and vascular research. Partnering these two universities will provide excellent teaching and support for trainees at both sites who are interested in working in the field of clinical research. The end result of this research will be improved health care to people in the underserved Appalachian community and the general population. Investigators at each institution are committed to the success of the network both in trial enrollment and in leadership roles.