ABSTRACT
Stroke remains a leading cause of death and disability in the US, with the situation in the southeastern states of North Carolina and Virginia being particularly severe. There are significant health disparities in stroke prevalence and stroke care between the Caucasian and non-Caucasian groups in this region. To address the critical need for promising interventions for stroke prevention, treatment, and recovery, and to improve stroke outcomes in under-represented groups, we propose a newly formed Duke-University of North Carolina (UNC) Eastern North Carolina and Southern Virginia RegIonal Stroke TrIal CONsortium (ENVISION) Regional Coordinating Center. The ENVISION RCC will consist of two major academic institutions, Duke and UNC, with 22 regional/community hospitals in eastern North Carolina and southern Virginia (including hospitals with various stroke center designations, pediatric hospital/services, and rehabilitation facilities). In this catchment area, we will draw stroke patients from a population of 4.9 million, predominantly in suburban and rural areas, with a large proportion from groups traditionally under-represented in clinical trials. Both institutions have successful track records in stroke research study recruitment, retention, and follow-up, and are supported by Clinical and Translational Science Awards (CTSAs). Our Center’s success will build upon strong, existing stroke clinical and research infrastructures and foundations: 1) strong, stroke educational, clinical, and research programs within the Duke- UNC hub; 2) robust patient volumes, pre-existing referring hospital networks, and prior close collaboration; 3) a dedicated, collaborative, multi-disciplinary leadership team [MPIs Drs. Wayne Feng (Duke, Vascular Neurology), Alexander Limkakeng (Duke, Emergency Medicine), and David Hwang (UNC, Neurocritical Care)]; 4) supportive junior faculty training and career development environments; and 5) strong institutional and departmental resource commitments. Through the following aims, we will contribute to the overall success of the NIH StrokeNet clinical trials network: Aim 1. Effectively enroll and retain a diverse population of stroke participants with high protocol adherence and high-quality data integrity with a balanced portfolio of stroke trials; Aim 2. Successfully identify, engage, and train the next generation of stroke scientists; and Aim 3. Actively contribute to the overall success of NIH StrokeNet leadership. As a new RCC, Duke-UNC ENVISION will optimize trial operations and provide high quality studies by leveraging its resources, expertise, experience, productivity, and commitment to inclusivity, thus contributing to StrokeNet goals to reduce stroke burden and improve stroke outcomes and health equity.
