BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit

NCT02190500 | Unknown Phase 2 DMC

• 1 other identifier: HSC 13-0322
• Study Type: interventional
• Target: 1,038
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this project is to carry out a trial comparing pre-hospital diagnosis and treatment of patients with stroke symptoms using a Mobile Stroke Unit (MSU) with subsequent transfer to a Comprehensive Stroke Center (CSC) Emergency Department (ED) for further management, to standard pre-hospital triage and transport by Emergency Medical Services (EMS) to a CSC ED for evaluation and treatment (Standard Management-SM).

Conditions

Acute Ischemic Stroke

Keywords

stroke; tpa; emergency medical service; ems; mobile; ct scan

Outcome Measures

Primary Outcomes (3)

• Utility-weighted modified Rankin Scale (uw-mRS) from baseline to 90 days

  Comparing patients found eligible for tPA (based on a blinded review of the patient's chart, regardless of whether they were treated or not) on MSU weeks compared to SM weeks. With a sample size of 693 total tPA-eligible patients (446 MSU and 247 SM patients, assuming 10% lost to follow-up), the study will have 80% power with a 0.05 Type I error rate to detect a difference between groups of 0.09 in the mean uw-mRS using a two-sample t-test.At total of 693 tPA treated patients will allow 85% power to detect a 25 min decrease in time to treatment between the two groups using a one- sided alpha level of 0.05

  90 days (+/- 10 days) from date of enrollment

• Agreement between on scene Vascular Neurologist vs. Remote (Telemedicine) Vascular Neurologist

  The agreement between a VN remotely assessing a suspected stroke patient via TM in the MSU and in-person assessment by a VN in the MSU will be assessed by using the Kappa statistic. We anticipate that the estimated sample size of 162 is needed to allow us 90 % power to detect 90% agreement between the in-person assessment and the TM.

  up to 4.5 hours from symptom onset

• Cost Effectiveness (N.B. The BEST-MSU study including measurement of heatlhcare utilization is funded by PCORI. The cost-effectiveness measures are not covered by PCORI funding and will be reported separately)

  Cost Effectiveness as measured by average patient QALYs, post-stroke healthcare utilization, incremental fixed costs associated with MSU and the per-patient incremental fixed cost due the ambulance outfitting, CT, other equipment, telemedicine technology and staffing requirements.

  up to 1 year from date of enrollment

Secondary Outcomes (6)

• 90 day Modified Rankin Score

  90 days (+/- 10 days) from date of enrollment

• 90 day Modified Rankin Score

  90 days (+/- 10 days) from date of enrollment

• Time from symptom onset to tPA treatment

  up to 4.5 hours from symptom onset

• Time from symptom onset to Endovascular treatment

  up to 6 hours from symptom onset

• Symptomatic intracranial hemorrhage and mortality

  up to hospital discharge

Study Arms (2)

Mobile Stroke Unit Management

ACTIVE COMPARATOR

Acute ischemic stroke patients treated in the Mobile Stroke Unit

Other: Mobile Stroke Unit Management

Standard Management

NO INTERVENTION

Acute ischemic stroke patients receiving standard management

Interventions

Mobile Stroke Unit Management OTHER

Mobile Stroke Unit is a standard 12' Houston Fire Department ambulance equipped with point of care lab, CT scanner and staffed by a Vascular Neurologist, Registered Nurse with acute stroke and research experience, CT Technician and a Registered EMT-P. The MSU is dispatched in coordination with Houston, Bellaire and West University fire department/emergency medical services.

Mobile Stroke Unit Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Last seen normal within 4hr 30 min of symptom onset
• History and physical/neurological examination consistent with acute stroke
• Informed consent obtained from patient (if competent) or legal representative.

You may not qualify if:

• None

Sponsors & Collaborators

• Memorial Hermann Health System: lead
• The University of Texas Health Science Center, Houston: collaborator
• Baylor College of Medicine: collaborator
• CHI St. Luke's Health, Texas: collaborator
• City of Houston Fire Department: collaborator
• The Methodist Hospital Research Institute: collaborator
• West University Fire Department: collaborator
• City of Bellaire Fire Department: collaborator
• Ben Taub Hospital: collaborator
• Harris Health: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Texas Health Science Center, Houston

Houston, Texas, 77030, United States

Location

Related Publications (7)

• Navi BB, Wang M, Yamal JM, Rajan SS, Czap AL, Parker SA, Nour M, Spokoyny I, Mir S, Fink ME, Willey JZ, Jones WJ, Grotta JC. Potential Missed Opportunities to Administer Intravenous Thrombolysis to Patients With Acute Ischemic Stroke. Stroke. 2026 Jan 29. doi: 10.1161/STROKEAHA.125.054326. Online ahead of print.

  PMID: 41608799 DERIVED

• Grotta JC, Yamal JM, Parker SA, Rajan SS, Gonzales NR, Jones WJ, Alexandrov AW, Navi BB, Nour M, Spokoyny I, Mackey J, Persse D, Jacob AP, Wang M, Singh N, Alexandrov AV, Fink ME, Saver JL, English J, Barazangi N, Bratina PL, Gonzalez M, Schimpf BD, Ackerson K, Sherman C, Lerario M, Mir S, Im J, Willey JZ, Chiu D, Eisshofer M, Miller J, Ornelas D, Rhudy JP, Brown KM, Villareal BM, Gausche-Hill M, Bosson N, Gilbert G, Collins SQ, Silnes K, Volpi J, Misra V, McCarthy J, Flanagan T, Rao CPV, Kass JS, Griffin L, Rangel-Gutierrez N, Lechuga E, Stephenson J, Phan K, Sanders Y, Noser EA, Bowry R. Prospective, Multicenter, Controlled Trial of Mobile Stroke Units. N Engl J Med. 2021 Sep 9;385(11):971-981. doi: 10.1056/NEJMoa2103879.

  PMID: 34496173 DERIVED

• Yamal JM, Parker SA, Jacob AP, Rajan SS, Bowry R, Bratina P, Wang M, Nour M, Mackey J, Collins S, Jones W, Schimpf B, Ornelas D, Spokoyny I, Im JF, Gilbert G, Eisshofer M, Grotta JC. Successful conduct of an acute stroke clinical trial during COVID. PLoS One. 2021 Jan 15;16(1):e0243603. doi: 10.1371/journal.pone.0243603. eCollection 2021.

  PMID: 33449944 DERIVED

• Czap AL, Singh N, Bowry R, Jagolino-Cole A, Parker SA, Phan K, Wang M, Sheth SA, Rajan SS, Yamal JM, Grotta JC. Mobile Stroke Unit Computed Tomography Angiography Substantially Shortens Door-to-Puncture Time. Stroke. 2020 May;51(5):1613-1615. doi: 10.1161/STROKEAHA.119.028626. Epub 2020 Apr 16.

  PMID: 32295510 DERIVED

• Bowry R, Parker SA, Yamal JM, Hwang H, Appana S, Rangel-Gutierrez N, Wu TC, Rajan SS, Grotta JC. Time to Decision and Treatment With tPA (Tissue-Type Plasminogen Activator) Using Telemedicine Versus an Onboard Neurologist on a Mobile Stroke Unit. Stroke. 2018 Jun;49(6):1528-1530. doi: 10.1161/STROKEAHA.117.020585. Epub 2018 May 2.

  PMID: 29720439 DERIVED

• Yamal JM, Rajan SS, Parker SA, Jacob AP, Gonzalez MO, Gonzales NR, Bowry R, Barreto AD, Wu TC, Lairson DR, Persse D, Tilley BC, Chiu D, Suarez JI, Jones WJ, Alexandrov A, Grotta JC. Benefits of stroke treatment delivered using a mobile stroke unit trial. Int J Stroke. 2018 Apr;13(3):321-327. doi: 10.1177/1747493017711950. Epub 2017 Jun 14.

  PMID: 28612680 DERIVED

• Wu TC, Parker SA, Jagolino A, Yamal JM, Bowry R, Thomas A, Yu A, Grotta JC. Telemedicine Can Replace the Neurologist on a Mobile Stroke Unit. Stroke. 2017 Feb;48(2):493-496. doi: 10.1161/STROKEAHA.116.015363. Epub 2017 Jan 12.

  PMID: 28082671 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• James C Grotta, MD

  Memorial Hermann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Alternating week assignment to groups. Entry criteria adjudicated by masked investigator. Primary outcome also by masked investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 15, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: August 1, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

US (1)