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Documents

 
  Announcement:  
Template letter to NIH StrokeNet Principal Investigators for restarting trial enrollment.
Within a month of suspension of enrollment, two trials had submitted a plan for reopening enrollment to the CIRB and a template letter for restarting trials was provided to all trial PIs to craft a trial-specific plan and request to CIRB to restart enrollment.
NIH StrokeNet Request to Reopen
 

GET INVOLVED:

  1. StrokeNet Concept Synopsis v3.0 Updated 1/31/2018
  2. Process for Solicitation and Review of Clinical Trials
  3. NINDS Stroke Trials Network
  4. StrokeNet Working Group Slide October 2019
  5. Proposal Development Process Flowchart v8 - June 2017

Funding Announcements:

  1. NOT-NS-14-043: Notice of Clarification of NINDS Policy for the Submission of Multi-site Clinical Trials in Stroke Treatment, Recovery, or Prevention
  2. PAR-20-285 NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (UG3/UH3 Clinical Trial Optional)  July 29, 2020
  3. PAR-17-277 NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention Infrastructure Resource Access (X01)  Expired 1/24/2018
  4. PAR-18-563: NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44 - Clinical Trial Optional)   Reissue 1/9/2018

NIH StrokeNet Funding Announcement:

  1. NOT-NS-17-019_ Notice of Intent to Publish a Funding Opportunity Announcement for NINDS StrokeNet Regional Coordinating Stroke Centers (U24)  Announcement Date May 2017
  2. StrokeNet Submission FAQs

Administrative Documents:

  1. StrokeNet Standard Operating Procedures (SOP's), Administrative and Good Clinical Practice 
  2. StrokeNet Start Up Site Communication Process Flowchart 6.4.2020
  3. Letters:
  4. Trial CTA Attachment 5 Documents
  5.  Competing Trials in StrokeNet Guidance April 2019
  6. MTAs & Changes in the Network

Central IRB:

  1. Institution-vs-IRB-responsibilities

Network Publications:

  1. National Institutes of Health StrokeNet Training Core Stroke.2020;51(1);347-352 Farhaan S. Vahidy, Cemal B. Sozener, Jennifer R. Meeks, Pratik Y. Chhatbar, Ciro Ramos-Estebanez, Maranatha Ayodele, Rebekah J. Richards, Richa Sharma, Stephanie M. Wilbrand, Shyam Prabhakaran, Barbara S. Bregman, Harold P. Adams Jr,Lori C. Jordan, David S. Liebeskind, David Tirschwell, L. Scott Janis, Randolph S. Marshall,Dawn Kleindorfer

  2. The AtRial cardiopathy and antithrombotic drugs in prevention after cryptogenic stroke randomized trial: Rationale and methods. Int J Stroke. 2019;14(2):207-214.Kamel H, Longstreth WT, Jr, Tirschwell DL, Kronmal RA, Broderick JP, Palesch YY, er al.

  3. Efficacy of home-based telerehabilitation vs in-clinic therapy for adults after stroke: A randomized clinical trial.  JAMA Neurol 2019;76(9):1079-1087 Cramer SC, Dodakian L, Le V, See J, Augsburger R, McKenzie A, et al.

  4. Thrombectomy for Strole at 6 to 16 Hours with Selection by Perfusion Imaging N Engl J Med. 2018;378((8):708-718 Albers GW, Marks MP, Kemp S, Christensen S, Tsai JP, Ortega-Grterriez S, et al.

  5. Study-aims-to-learn-more-about-silent-infarction-cognitive-decline-linked-to-silent-stroke The University of Alabama at Birmingham 

  6. Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging. N Engl J Med. 2018 Feb 22;378(8):708-718.  G.W. Albers, M.P. Marks, S. Kemp, S. Christensen, J.P. Tsai, S. Ortega‑Gutierrez, R.A. McTaggart, M.T. Torbey, M. Kim‑Tenser, T. Leslie‑Mazwi, A. Sarraj, S.E. Kasner, S.A. Ansari, S.D. Yeatts, S. Hamilton, M. Mlynash, J.J. Heit, G. Zaharchuk, S. Kim, J. Carrozzella, Y.Y. Palesch, A.M. Demchuk, R. Bammer, P.W. Lavori, J.P. Broderick, and M.G. Lansberg, for the DEFUSE 3 Investigators*
                                     
  7. Stroke Recovery and Rehabilitation Research Issues, Opportunities, and the National Institutes of Health StrokeNet. Stroke. 2017;48:813-819. Originally published February 7, 2017. Steven C. Cramer, MD; Steven L. Wolf, PhD; Harold P. Adams, Jr, MD; Daofen Chen, PhD; Alexander W. Dromerick, MD; Kari Dunning, PT, PhD; Caitlyn Ellerbe, PhD; Andrew Grande, MD; Scott Janis, PhD; Maarten G. Lansberg, MD; Ronald M. Lazar, PhD; Yuko Y. Palesch, PhD; Lorie Richards, PhD; Elliot Roth, MD; Sean I. Savitz, MD; Lawrence R. Wechsler, MD; Max Wintermark, MD; Joseph P. Broderick, MD.
     
  8. StrokeNet Takes Off National Institute of Neurological Disorders and Stroke Organizational Update.  Stroke. 2016;47:e51-e52Originally published January 26, 2016. Meghan Mott, Scott Janis, Walter J. Koroshetz.
     
  9. The NIH StrokeNet A Users GuideStroke. 2016;47:301-303. Originally published December 29, 2015. Broderick JP, Palesch YY, Janis LS for the National Institutes of Health StrokeNet Investigators.
     
  10. Imaging in StrokeNet Realizing the Potential of Big Data. Stroke. 2015;46:2000-2006. Originally published June 4 2015. David S. Liebeskind, Gregory W. Albers, Karen Crawford, Colin P. Derdeyn, Mark S. George, Yuko Y. Palesch, Arthur W. Toga, Steven Warach, Wenle Zhao, Thomas G. Brott, Ralph L. Sacco, Pooja Khatri, Jeffrey L. Saver, Steven C. Cramer, Steven L. Wolf, Joseph P. Broderick and Max Wintermark.

Research Practice Publications:

  1. How Nurses Can Partner With National Institutes of Health StrokeNet to Deliver Best Research and Care to Stroke Patients. Stroke. 2017;STROKEAHA.117.017872 . Originally published December 4, 2017. Jamey Frasure, Judith Spilker
  2. Power of an Adaptive Trial Design for Endovascular Stroke Studies: Simulations Using IMS (Interventional Management of Stroke) III Data. Stroke. 2016;47:2931-2937. Originally published November 15, 2016
    Maarten G. Lansberg, Ninad S. Bhat, Sharon D. Yeatts, Yuko Y. Palesch, Joseph P. Broderick, Gregory W. Albers, Tze L. Lai and Philip W. Lavori
  3. Stroke Treatment Academic Industry Roundtable: The Next Generation of Endovascular Trials. Stroke. 2016;47:2656-2665. Originally published September 1, 2016
    Tudor G. Jovin, Gregory W. Albers, David S. Liebeskind and for the STAIR IX Consortium
  4. Stroke Treatment Academic Industry Roundtable Recommendations for Individual Data Pooling Analyses in Stroke. 2016;47:2154-2159. Originally published July 12, 2016
    Kennedy R. Lees, Pooja Khatri, for the STAIR IX Collaborators