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