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Michigan StrokeNet (RCC 17)
University of Michigan
1
What is NIH StrokeNet
• National Clinical Trial Network
• Designed to Conduct Multi‐site Phase 1 to Phase 3
Trials and biomarkers studies.
• Specifically focusing on:
o Stroke Prevention
o Acute Stroke Treatment
o Post-stroke Recovery Trials.
• Centralized infrastructure for contracts, IRBs, managing
data, and running trials.
• 25 regional centers and 255 associated hospitals thus
far.
Michigan StrokeNet RCC
Executive Team
• Phillip A. Scott, MD, Co-PI
• Devin Brown, MD, Co-PI
• Lewis Morgenstern, MD, Training Director
• Sherry Goldfarb, MPH, Project Manager
4
Michigan StrokeNet Coverage (2013)
5
Michigan StrokeNet (Oct 2016)
6
Interactions with Other Networks
• NETT / SIREN
• NeuroNext
• CASTOR
• International Networks
o European
o Japan
o China
7
Current Trials
Site StrokeNet/
NINDS Trials
Pending
StrokeNet
Trials
Non-NINDS Trials
University of
Michigan Health
System
SHINE
MISTIE- III
CREST- 2
DEFUSE-3 NAVIGATE ESUS
Wayne State
University/
Detroit Medical
Center
SHINE SOCRATES
DALF-PS-1016
Sunovion/SanBio SB-
STR02 study
Mercy Heath St.
Mary’s Grand
Rapids
POINT CREST-2
MISTIE-III
IMPACT
DEFUSE –3
DALF-PS-1016
RESPECT ESUS
University of
Kentucky
Medical Center
SHINE
POINT
ATACH-II
CREST-2 PRISMS
NAVIGATE ESUS
8
Performance
Brady Hoke Jim Harbaugh
9
2014 Record: 5W – 7L
Record (to date): 20W – 6L
… OSU watch out…
DEFUSE 3 Enrollment
(n = 114, Feb 2, 2017)
TELEREHAB
(n = 77; Feb 14, 2017)
Acute Stroke Primary and Secondary
Prevention
Recovery and Rehabilitation
• Chair: Pooja Khatri University of
Cincinnati
• Co-chair: Jeff Saver UCLA
• Renee’ Martin NDMC
• Greg Albers Imaging Core
• David Liebeskind Imaging Core
• TBD Minority Recruitment and
Retention
• Bill Barsan University of Michigan (ad
hoc NETT member)
• Lee Schwamm Massachusetts General
Hospital
• Ed Jauch Medical University of South
Carolina
• Brett Meyer UC San Diego
• Phil Scott University of Michigan
• Jay Mocco Mt. Sinai School of Medicine
– (#2)
• Cathy Sila Case Western Reserve
University School of Medicine
• Wade Smith UC San Francisco
• Azam Ahmed University of Wisconsin
• Michel Torbey The Ohio State
University
• Coordinator: Kiva Schindler Emory
University
• Chair: Tom Brott Mayo Clinic
Jacksonville
• Co-Chair: Ralph Sacco University of
Miami School of Medicine
• Sharon Yeatts NDMC
• Colin Derdeyn Imaging Core
• Steve Warach Imaging Core
• Bernadette Boden-Albala PhD. Mt.
Sinai School of Medicine/New York
City Collaborative Minority
Recruitment and Retention
• Amy Towfighi USC/UCLA
• Scott Kasner University of
Pennsylvania
• Kamakshi Lakshminarayan University
of Minnesota
• David Tirschwell University of
Washington
• Shyam Prabhakaran Northwestern
University
• Enrique Leira University of Iowa
• Marc Chimowitz Medical University
of South Carolina
• Natalia Rost Massachusetts General
Hospital
• Coordinator: Glenn Schubert
University of Washington
• Chair: Steve Cramer UC Irvine
• Co-chair: Steve Wolf PhD Emory
University
• NINDS representative: Daofen Chen,
PhD
• Caitlyn Ellerbe NDMC
• Max Wintermark Imaging Core
• TBD Minority Recruitment and
Retention
• Ron Lazar Columbia University
• Alex Dromerick The Medstar Research
Institute
• Larry Wechsler University of
Pittsburgh
• Sean Savitz University of Texas at
Houston
• Lorie Gage Richards University of Utah
• Maarten Lansberg Stanford University
• Andrew Grande University of
Minnesota
• Elliot Roth Northwestern University
• Harold Adams University of Iowa
• Kari Dunning University of Cincinnati
(ad hoc)
• Coordinator: Mary Pautler University
of Utah
STROKENET: Working Groups
StrokeNet Trial Protocol Development
from UM
Clinical trial protocol development
PreLIMBS (submitted): Neeraj Chaudhary, MD
PAP trial (in feasibility stage): Devin Brown,MD; Ronald
Chervin, MD
CoolCap (development): William Meurer,MD; Cemal
Sozener, MD
13
StrokeNet Training Program
Cemal Sozener, MD
• Assistant Professor, Dept of Emergency Medicine,
University of Michigan
• Focus on clinical stroke training and stroke trial
development
• Exploring economic impact and geographic access to
stroke care
• Completed NINDS Clinical Trials Methodology course
(July 2015)
• Mentoring with Drs. Scott and Meurer
• Work selected for ISC and StrokeNet presentations
• Selected to national StrokeNet Training committee
15
Cemal Sozener, MD
Manuscripts Presentations
Economic Impact of the INSTINCT
Trial, submitted
Economic impact of increasing
community delivery of tPA via the
INSTINCT Project, ISC StrokeNet
fellow presentation
geospatial analysis of the StrokeNet
sites looking at access to stroke-related
clinical trials for different
socioeconomic classes within acute
care, rehab and pediatric centers
2015 invited speaker Florida Stroke
Symposium
2015 invited speaker New England
Cerebrovascular Conference (NECC)
2016 moderated poster accepted ISC
Clinical trial development Other activities
Targeted hypothermia in acute
ischemic stroke
NINDS Clinical Trials Methods
Course
StrokeNet Education Core 16
Looking Ahead…
17
In Summary…
• Multiple persons in this room today have had their family
impacted by stroke
• ALL NIH clinical stroke trials will be conducted through the
network!
• We are here to help you implement your trial faster, better,
stronger than in days past.
• EM is THE front door for all acute care stroke trials
• EM is an opportunity for primary and secondary stroke
prevention trials
• StrokeNet is THE place to make a difference - by participating
in trials, enhancing your training, and developing and leading
your own trial
18
As Jerry Maguire said…
19
Thank You!
20

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Michigan StrokeNet by Phillip Scott

  • 1. Michigan StrokeNet (RCC 17) University of Michigan 1
  • 2. What is NIH StrokeNet • National Clinical Trial Network • Designed to Conduct Multi‐site Phase 1 to Phase 3 Trials and biomarkers studies. • Specifically focusing on: o Stroke Prevention o Acute Stroke Treatment o Post-stroke Recovery Trials. • Centralized infrastructure for contracts, IRBs, managing data, and running trials. • 25 regional centers and 255 associated hospitals thus far.
  • 3.
  • 4. Michigan StrokeNet RCC Executive Team • Phillip A. Scott, MD, Co-PI • Devin Brown, MD, Co-PI • Lewis Morgenstern, MD, Training Director • Sherry Goldfarb, MPH, Project Manager 4
  • 7. Interactions with Other Networks • NETT / SIREN • NeuroNext • CASTOR • International Networks o European o Japan o China 7
  • 8. Current Trials Site StrokeNet/ NINDS Trials Pending StrokeNet Trials Non-NINDS Trials University of Michigan Health System SHINE MISTIE- III CREST- 2 DEFUSE-3 NAVIGATE ESUS Wayne State University/ Detroit Medical Center SHINE SOCRATES DALF-PS-1016 Sunovion/SanBio SB- STR02 study Mercy Heath St. Mary’s Grand Rapids POINT CREST-2 MISTIE-III IMPACT DEFUSE –3 DALF-PS-1016 RESPECT ESUS University of Kentucky Medical Center SHINE POINT ATACH-II CREST-2 PRISMS NAVIGATE ESUS 8
  • 9. Performance Brady Hoke Jim Harbaugh 9 2014 Record: 5W – 7L Record (to date): 20W – 6L … OSU watch out…
  • 10. DEFUSE 3 Enrollment (n = 114, Feb 2, 2017)
  • 11. TELEREHAB (n = 77; Feb 14, 2017)
  • 12. Acute Stroke Primary and Secondary Prevention Recovery and Rehabilitation • Chair: Pooja Khatri University of Cincinnati • Co-chair: Jeff Saver UCLA • Renee’ Martin NDMC • Greg Albers Imaging Core • David Liebeskind Imaging Core • TBD Minority Recruitment and Retention • Bill Barsan University of Michigan (ad hoc NETT member) • Lee Schwamm Massachusetts General Hospital • Ed Jauch Medical University of South Carolina • Brett Meyer UC San Diego • Phil Scott University of Michigan • Jay Mocco Mt. Sinai School of Medicine – (#2) • Cathy Sila Case Western Reserve University School of Medicine • Wade Smith UC San Francisco • Azam Ahmed University of Wisconsin • Michel Torbey The Ohio State University • Coordinator: Kiva Schindler Emory University • Chair: Tom Brott Mayo Clinic Jacksonville • Co-Chair: Ralph Sacco University of Miami School of Medicine • Sharon Yeatts NDMC • Colin Derdeyn Imaging Core • Steve Warach Imaging Core • Bernadette Boden-Albala PhD. Mt. Sinai School of Medicine/New York City Collaborative Minority Recruitment and Retention • Amy Towfighi USC/UCLA • Scott Kasner University of Pennsylvania • Kamakshi Lakshminarayan University of Minnesota • David Tirschwell University of Washington • Shyam Prabhakaran Northwestern University • Enrique Leira University of Iowa • Marc Chimowitz Medical University of South Carolina • Natalia Rost Massachusetts General Hospital • Coordinator: Glenn Schubert University of Washington • Chair: Steve Cramer UC Irvine • Co-chair: Steve Wolf PhD Emory University • NINDS representative: Daofen Chen, PhD • Caitlyn Ellerbe NDMC • Max Wintermark Imaging Core • TBD Minority Recruitment and Retention • Ron Lazar Columbia University • Alex Dromerick The Medstar Research Institute • Larry Wechsler University of Pittsburgh • Sean Savitz University of Texas at Houston • Lorie Gage Richards University of Utah • Maarten Lansberg Stanford University • Andrew Grande University of Minnesota • Elliot Roth Northwestern University • Harold Adams University of Iowa • Kari Dunning University of Cincinnati (ad hoc) • Coordinator: Mary Pautler University of Utah STROKENET: Working Groups
  • 13. StrokeNet Trial Protocol Development from UM Clinical trial protocol development PreLIMBS (submitted): Neeraj Chaudhary, MD PAP trial (in feasibility stage): Devin Brown,MD; Ronald Chervin, MD CoolCap (development): William Meurer,MD; Cemal Sozener, MD 13
  • 15. Cemal Sozener, MD • Assistant Professor, Dept of Emergency Medicine, University of Michigan • Focus on clinical stroke training and stroke trial development • Exploring economic impact and geographic access to stroke care • Completed NINDS Clinical Trials Methodology course (July 2015) • Mentoring with Drs. Scott and Meurer • Work selected for ISC and StrokeNet presentations • Selected to national StrokeNet Training committee 15
  • 16. Cemal Sozener, MD Manuscripts Presentations Economic Impact of the INSTINCT Trial, submitted Economic impact of increasing community delivery of tPA via the INSTINCT Project, ISC StrokeNet fellow presentation geospatial analysis of the StrokeNet sites looking at access to stroke-related clinical trials for different socioeconomic classes within acute care, rehab and pediatric centers 2015 invited speaker Florida Stroke Symposium 2015 invited speaker New England Cerebrovascular Conference (NECC) 2016 moderated poster accepted ISC Clinical trial development Other activities Targeted hypothermia in acute ischemic stroke NINDS Clinical Trials Methods Course StrokeNet Education Core 16
  • 18. In Summary… • Multiple persons in this room today have had their family impacted by stroke • ALL NIH clinical stroke trials will be conducted through the network! • We are here to help you implement your trial faster, better, stronger than in days past. • EM is THE front door for all acute care stroke trials • EM is an opportunity for primary and secondary stroke prevention trials • StrokeNet is THE place to make a difference - by participating in trials, enhancing your training, and developing and leading your own trial 18
  • 19. As Jerry Maguire said… 19

Editor's Notes

  1. Added “(submitted)” to PreLIMBS. Added Ron Chervin to PAP trial Added “(development)” to coolcap