The New York Stroke Trials Network of Columbia and Cornell (NYSTNCC) will be established with the goal of maximizing stroke clinical trial enrollment for our region. Columbia and Cornell, situated on the west and east side of Manhattan, respectively, will form the two hubs, supported by an additional Acute Treatment Sub-network of 3 hospitals in Brooklyn and New Jersey --and a Recovery Sub-network comprising 3 affiliated academic Rehabilitation Centers in Westchester County and New Jersey. Our hubs have an extensive leadership record in stroke clinical trials. Columbia and Cornell have been involved in 44 human stroke studies in the last 5 years alone, including 29 stroke clinical trials, 10 stroke biomarker studies, and 5 stroke outcomes studies. Of the currently active stroke studies at hubs and sub-network sites, over 1,200 patients have been enrolled. Each sub-network site has clinical trials experience, and a track record of stroke clinical trial enrollment, enabling them to start implementing trials as soon as the Network is operational. Our 16 affiliated Hospitals will form a referral network for the environment. The demographics in our network overall are very favorable for enrolling underserved minority populations: Columbia 40% Hispanic and 25% African American;Cornell 15% Asian, and St. Joseph's 24% African American, 30% Hispanic, 12% other. Three innovative phase-2 clinical trials in each of the cardinal areas - acute treatment, prevention, and recovery - are proposed, along with a pediatric stroke project. The Network will include co-investigators from Neurology, Neurosurgery, Radiology, Emergency Medicine, Interventional Neuroradiology and Rehabilitation Medicine with a wide range of high-level stroke-related expertise. To maximize enrollment at each site, we will hold monthly sessions in the first 6 months to train site coordinators on our surveillance and enrollment methods, including how to negotiate EMR systems, how to approach patients with stroke deficits, language to use for surrogate enrollment, and how to ensure accurate data entry. We will also hold quarterly research update meetings by videoconference that will include the hubs, sub-network sites, and referral hospitals. Our basic scientists will support the clinical trials by helping to generate ideas for new proposals and by providing basic science context for new projects being proposed at the national level. Basic and clinical science senior faculty at Columbia and Cornell will mentor junior faculty and train one Vascular Neurology Research Fellow per year. We propose to continue the highly successful monthly Webinar series that Dr. Marshall initiated through our SPOTRIAS grant, which we hope to implement at the national level.

Public Health Relevance

Stroke is the 4th leading cause of death and the leading cause of disability in the US. Our aging population makes prevalence of stroke likely to rise in the next decade. Only through diligent and efficient clinical trial completion can we hope to mitigate this important trend in national mortality. The NYSTNCC is specifically designed to contribute substantially to this effort.

Agency
National Institute of Health (NIH)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10NS086728-02
Application #
8739699
Study Section
Special Emphasis Panel (ZNS1)
Program Officer
Vivalda, Joanna
Project Start
Project End
Budget Start
Budget End
Support Year
2
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Columbia University (N.Y.)
Department
Neurology
Type
Schools of Medicine
DUNS #
City
New York
State
NY
Country
United States
Zip Code
10032