Stroke is a common neurological disease and is a growing major public health problem. Although mortality is declining, it remains the number four cause of none-accidental death in the U.S. It is still the leading cause of major disability, and as the population ages and becomes more diverse, the number of affected individuals is expected to significantly grow. The mission of NINDS is to reduce the burden of neurological disease and stroke. Multicenter clinical trials are key in advancing the science and practice of stroke treatment. National Institutes of Health funded clinical trials have often suffered from long start up time and delays in completing the research. Disease specific research consortiums are part of a national trend to improve these deficiencies by providing a common infrastructure that will facilitate the design, startup, and conduct of multicenter trials, streamlining site selection, research team organization, and human subject protection. It will minimize the need to reorganize the research team for every new trial. Enhanced collaboration will result from such a network, and will function as an incubator for new research and provide a rich environment for research training. The StrokeNET network was created in 2013 to achieve those goals. The University of Minnesota (UMN) and its stroke program are uniquely qualified to serve a Regional Coordinating Center. It has access to a broad set of academic researchers relevant for this field, with depth in various domains of clinical research. It has extensive experience in implementing research networks, proven as a current member in StrokeNet, and collaboration with the University of Minnesota hub of SIREN (Strategies to Innovate EmeRgENcy Care Clinical Trials Network, the NINDS/NHLBI emergency medicine research network), as well as the previous experience and relationships built by being part of the two previous funding cycles of the NINDS Neurological Emergency Research Network (NETT). The leaders for this application are experienced in stroke clinical research, managing research networks, and are experts in the subject matter. The various specialties needed to collaborate for successful implementation of the trials are already aligned administratively in collaborative units beyond traditional departments. Within the previous cycle of StrokeNET, our regional center contributed significantly to the network, participating in seven clinical trials with the total number of subjects recruited within the top tier of all RCC?s, a very high rate of patient retention, subject follow-up and document completion. We have actively engaged with 13 hospitals regionally that have recruited patients into network trials. We have brought two proposals for investigator initiated trials and served on several key committees within the network. We have trained four StrokeNet fellows and a team member served on the education committee. Overall, the current stroke program at the University of Minnesota is an excellent candidate to renew its role as an NIH StrokeNet Regional Coordinating Center.

Public Health Relevance

Stroke is a common neurological disease and is a growing major public health problem. NINDS has created the StrokeNet research network to improve conduct of large multicenter stroke clinical trials, by providing a common infrastructure, minimizing delays and improving efficiency. The University of Minnesota is a currently awarded Regional Coordinating Stroke Center (RCC) in the NIH StrokeNet clinical trials network and is seeking renewal of this work. The University of Minnesota RCC will contribute to the network goals of developing, promoting and conducting high-quality, multi-site clinical trials focused on key interventions in stroke prevention, treatment, and recovery.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Resource-Related Research Projects--Cooperative Agreements (U24)
Project #
5U24NS107269-03
Application #
9993571
Study Section
Special Emphasis Panel (ZNS1)
Program Officer
Vivalda, Joanna
Project Start
2018-08-15
Project End
2023-07-31
Budget Start
2020-08-01
Budget End
2021-07-31
Support Year
3
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of Minnesota Twin Cities
Department
Neurology
Type
Schools of Medicine
DUNS #
555917996
City
Minneapolis
State
MN
Country
United States
Zip Code
55455