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NIH StrokeNet Trials Network
Jose G. Romano, MD, FAHA, FAAN Chief, Stroke Division, University of Miami Miller School of Medicine
Society of Vascular and Interventional Neurology
Hollywood, FL November 9th, 2014
Presenter Disclosure Information
Jose G. Romano
Unlabeled or unapproved uses disclosure: None
Relevant Disclosures:
• StrokeNet Miami RCC PI (R. Sacco, co-PI), NINDS
• FL-PR Collaboration to Reduce Stroke Disparities, Core B PI (Program PI R. Sacco), NINDS
• MaRISS Study, PI, Genentech
• Steering Committee, PRISMS Trial, Genentech
Background
• Encouraging advances in acute stroke treatment and prevention
• Introduction of novel interventions slow and expensive
– Many clinical trials have been stopped due to poor enrollment
– Competing trials, lack of commitment, administrative hurdles
– Recent review stroke trials: 78% sites contribute
Background: ongoing and past Stroke Trials
http://clinicaltrials.gov/ct2/results/map?term=Stroke. Accessed 11/8/2014
http://clinicaltrials.gov/ct2/results/map?term=Strokehttp://clinicaltrials.gov/ct2/results/map?term=Stroke
Background
• Research networks feasible: SPOTRIAS, NeuroNext, NETT
• Efficient networks: recruitment efficiency, fast study completion,
centralization resources, know-how preservation, decrease
overlap, harmonize results, decrease costs*
Stroke Research Priorities Meeting. NINDS 2012
NIH Stroke Trials Network: StrokeNet
• National Coordinating Center: University of Cincinnati • National Data Management Center: MUSC • 25 Regional Coordinating Centers: over 200 hospitals
StrokeNet Implementation
• Multicenter trials in acute stroke, stroke prevention,
rehabilitation, pediatric stroke, exploratory early phase
studies and bio-marker studies.
• All multicenter stroke studies will be considered for
implementation through StrokeNet.
• All StrokeNet studies will use central coordination through
NCC, data management through DMC, patient recruitment
through RCC.
EXECUTIVE Committee
STEERING Committee
OPERATIONS Committee
NINDS/Scientific Advisory
Leadership
Data
Management
CenterMedical University of
South Carolina
National Coordinating
Center and Central
Pharmacy
University of Cincinnati
Regional Coordinating
Centers (N=25)
Satellite Sites/Clinical
Performace Sites
Protocol Awarded
Centers
NON-Network
CORES
Imaging
Education
ADVISORY
COMMITTEES
WORKING
GROUPS
Acute Stroke
Prevention
Rehab/Recovery
DSMB
Central IRB
University of Cincinnati
StrokeNet Organization
Committees, Working Groups and Cores
• Executive Committee: J. Broderick (NCC PI), Yuko Palesch (DMC PI), Scott Janis (NINDS), NCC Staff & 3 rotating RCC members
• Steering Committee: J. Broderick (NCC PI), Yuko Palesch (DMC PI), Scott Janis (NINDS), RCC PIs
• Prevention (Chair T. Brott, Co-chair R. Sacco)
• Acute Stroke Treatment (Chair P. Khatri, Co-chair J. Saver)
• Recovery/Rehabilitation (Chair S. Cramer, Co-chair S. Wolf)
• Educational Core (Chair M. Wintermark)
• Imaging Core (Chair D. Kleindorfer, Co-chair R. Marshall)
Increasing Efficiency of the Network
• Master Trial Agreement (MTA)
Single agreement between UC & RCC, satellites
Each trial is an amendment to MTA
• Central IRB Reliance Agreement (RA)
UC IRB
Chair: Michael Finke, PhD, CIP
Liaison: Sarah Morabito, JD, MBA
• Central and Regional SOPs
NCC DMC
MTAs cIRB
RCC RCC
Satellite Satellite
Satellite
Satellite Satellite
Satellite
NIH
NCC DMC
MTAs cIRB
RCC RCC
Satellite Satellite
Satellite
Satellite Satellite
Satellite
NIH
Primary and Secondary Prevention Trials
CREST 2 (NCT02089217)
Acute Interventional Stroke Trials
MISTIE III (NCT01827046)
I-DEF (NCT02175225)
Ongoing Studies in StrokeNet
• Tele-rehabilitation in Patients with Stroke
• EnDovascular ThErapy Following Imaging EvalUation
for ISchemic StrokE (DEFUSE 3)
• The Intravascular Cooling in the Treatment of Stroke 3
(ICTuS 3)
• Minimizing Onset to Stroke Treatment Time Trial
(MOST)
Studies being considered by StrokeNet
Training the New Generation of Stroke Researchers
• Each regional coordinating center has funds for a Stroke Research Fellowship position.
• Does not need to be necessarily a stroke neurology fellow.
• Formal training in research methodology, mentorship,
participates in recruitment activities
• Networking
• Fellow/Trainee Directory
• Job Postings
Available lectures on StrokeNet website http://www.nihstrokenet.org/education
• Neuroimaging Characterization of Brain Plasticity in Aging and Stroke: V Prabhakaran
• Thrombolysis in Pediatric Stroke: R Ichord • Next Generation Drugs for Neuroprotection in Acute
Ischemic Stroke: B McLaughlin • Tips & Tricks for Writing your CV and Biosketch: D
Kleindorfer • Pathophysiological Links between Migraine and
Stroke: C Ayata • Inflammatory Biomarkers in Acute Stroke and
Stroke Prevention: M Elkind • Brain Susceptibility to Acute Ischemia: N Rost • Targets for neural repair therapies after stroke: T
Carmichael • Dynamic Blood Pressure Management in Acute
Stroke: K Guluma • Cerebral Hemodynamics and Brain Function: R
Marshall • Of Microbleeds and Macrobleeds: S Greenberg • Reducing Door-to-Needle Times using Toyota's Lean
Process Improvement: A Ford • Gloves Off for Acute Stroke: J Choe, J Hinman, • Stent Retrievers in Acute Stroke: R Jahan
• Challenges to Enrollment in Clinical Trials: J Broderick • Using Oxygen Metabolism to Define the Ischemic
Penumbra: JM Lee • Pediatric Stroke: J Lynch • Endovascular Treatment in Acute Stroke: J Broderick • Improving Acute Stroke Care Delivery: L Schwamm • Minimally Invasive Rx IVH: P Vespa • New Therapies for ICH: N Gonzales • Hypothermia: T Hemmen • Management of Brain AVMs: JP Mohr • Cell Therapy and Stroke: S Savitz • Cerebral Hemodynamics: D Liebeskind • Gene Hunting for Stroke and Other Complex
Phenotypes: J Rosand • TeleStroke 101 - The Evidence: Brett C. Meyer • Imaging as a Surrogate Marker of Outcomes in Stroke: S
Warach • Intracranial Atherosclerotic Disase (ICAD): C Derdeyn • Statins in Stroke Treatment: M Elkind • Stroke Recovery: Timing and Neuroimaging Evidence: R
Marshall • Hemorrhagic Transformation of Ischemic Infarct: Khatri • Sonothrombolysis: Ultrasound in Acute Stroke: Barreto
http://www.nihstrokenet.org/education
Date Topic Speaker
Nov 20 Cell-Based Therapies for Stroke Sean Savitz
Jan 29 Gloves Off for Acute Stroke Management “New Combatants”:
Fellow case Presentations to 2 Stroke Experts
Harold Adams/Greg
Albers and Fellows
Feb 26 Telemedicine in Practice and Research Lee Schwamm
Mar 26 Aphasia and Language Recovery Ronald Lazar
April 30 Post Stroke Fatigue Kyra Becker
May 28 High Resolution Cerebrovascular Vessel Wall Imaging Thomas Hatsukami
June 25 Ethics in Acute Research and Emergency Medicine Michelle Biros
Upcoming NIH StrokeNet Webinar 2014 – 2015
StrokeNet website https://www.nihstrokenet.org