Acute Ischemic StrokePhase 2/3BEST-MSUNCT02190500
BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit
A Phase 2/3 study testing Mobile Stroke Unit Management in people with Acute Ischemic Stroke, run by Memorial Hermann Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Mobile Stroke Unit Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,038 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Aug 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Last seen normal within 4hr 30 min of symptom onset
- History and physical/neurological examination consistent with acute stroke
- No tPA exclusions per guidelines, prior to CT scan or baseline labs
- Informed consent obtained from patient (if competent) or legal representative.
Who cannot join
- -None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center, Houston
Houston, Texas, 77030
About this study
Official title: BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services:The BEST-MSU Study
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).
Read the detailed description
There are many ways that use of a MSU might prove valuable in stroke patients, but we will focus on acute ischemic stroke (AIS) and treatment with IV tissue plasminogen activator (tPA) within 4.5 hours of symptom onset since that is the most evidence based effective emergency treatment for the most prevalent stroke diagnosis. We hypothesize that the MSU pathway will result in an overall shift towards earlier evaluation and treatment, particularly into the first hour after symptom onset, leading to substantially better outcome. We also hypothesize that as a result of improved clinical outcomes resulting from earlier treatment, the costs of a MSU program will be offset by a reduction in the costs of long term stroke care and increase in quality adjusted life years, thereby supporting more widespread use of this technology. To make MSU deployment more practical, we will confirm that a Vascular Neurologist (VN) on board the MSU can be replaced by a remote VN connected to the MSU by telemedicine (TM) thereby reducing manpower requirements and costs.
The successful completion of this project will provide data on important outcomes and costs associated with the use of MSU vs SM in the United States (U.S.) that will help determine the value of integrating MSUs into the pre-hospital environment in this country. Successfully addressing our three Specific Aims (time saved/ complications encountered, utility of TM, and cost effectiveness) will provide critical information that will be needed to determine if and how a subsequent more definitive study should be conducted. We anticipate that emanating from this exploratory study would be a larger multicenter trial carried out in both urban and rural U.S. pre-hospital environments, with treatment orchestrated via TM, and having sufficient power to determine a difference in long term outcome and costs between patients managed on the two pathways, following a study design that will be tested in this exploratory trial. The present study, therefore, is the necessary first step in a process which may dramatically modify the way that acute stroke patients are managed in the U.S.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Mobile Stroke Unit Management
- Keywords
- stroke, tpa, emergency medical service, ems, mobile, ct scan
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Stroke Unit ManagementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Stroke Unit Management | Active comparator | Acute ischemic stroke patients treated in the Mobile Stroke Unit Receives: Other: Mobile Stroke Unit Management |
| Standard Management | No intervention | Acute ischemic stroke patients receiving standard management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: up to 1 year from date of enrollment
Secondary outcomes (6)
90 day Modified Rankin Score
90 day Modified Rankin Score 0,1 vs 2-6, and ordinal shift analysis, of patients treated with tPA within 60 minutes of symptom onset according to published guidelines on either MSU or SM weeks, compared to similar patients treated 61-270 minutes after onset, adjusting for any imbalances in stroke severity (baseline NIHSS) between the groups at the time of treatment.
Measured: 90 days (+/- 10 days) from date of enrollment
90 day Modified Rankin Score
90 day Modified Rankin Score 0,1 vs 2-6, and ordinal shift analysis, of all patients meeting published guidelines for treatment with tPA within 4.5 hours of symptom onset (whether eventually treated or not) on MSU weeks compared to patients meeting the same criteria (whether treated or not) on SM weeks, adjusting for any imbalances in stroke severity (baseline NIHSS) between the groups at the time of treatment.
Measured: 90 days (+/- 10 days) from date of enrollment
Time from symptom onset to tPA treatment
The time from LSN to tPA treatment on all patients treated within 4.5 hours of LSN on MSU weeks compared to similarly eligible patients on SM weeks.
Measured: up to 4.5 hours from symptom onset
Time from symptom onset to Endovascular treatment
The time from LSN and from ED arrival to start of endovascular procedure (intra-arterial thrombectomy-IAT) in patients who meet pre-specified criteria for IAT on MSU weeks compared to SM weeks.
Measured: up to 6 hours from symptom onset
Symptomatic intracranial hemorrhage and mortality
The incidence of symptomatic intracranial hemorrhage (sICH) and mortality in tPA treated patients on MSU weeks compared to SM weeks (Symptomatic intracranial hemorrhage defined as any intracranial blood accumulation associated with a clinical deterioration of 4 points of the NIHSS for which the hemorrhage has been identified as the dominating cause of the neurologic deterioration)
Measured: up to hospital discharge
Stroke mimics
The incidence of stroke mimics and transient ischemic attacks (TIAs) in tPA treated patients on MSU weeks compared to SM weeks.
Measured: up to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2021
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,038 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Hermann Health System
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, Baylor College of Medicine, CHI St. Luke's Health, Texas, City of Houston Fire Department, The Methodist Hospital Research Institute, West University Fire Department, City of Bellaire Fire Department, Ben Taub Hospital, Harris Health, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, James Grotta, MD, Memorial Hermann Health System
- Investigators
- James C Grotta, MD, Principal investigator, Memorial Hermann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190500
- Sponsor's protocol ID
- HSC 13-0322
- Acronym
- BEST-MSU
- Status last verified
- Mar 2023
- First submitted
- 10 Jul 2014
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 Mar;57(3):633-640. doi: 10.1161/STROKEAHA.125.054326. Epub 2026 Jan 29.
PubMed 41608799Grotta 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.
PubMed 34496173Yamal 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.
PubMed 33449944Czap 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.
PubMed 32295510Bowry 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.
PubMed 29720439Yamal 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.
PubMed 28612680Wu 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.
PubMed 28082671
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services:The BEST-MSU Study
- ClinicalTrials.gov ID
- NCT02190500
- Acronym / sponsor ID
- BEST-MSU / HSC 13-0322
- Conditions
- Acute Ischemic Stroke
- Keywords
- stroke, tpa, emergency medical service, ems, mobile, ct scan
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,038 participants (actual)
- Lead sponsor
- Memorial Hermann Health SystemUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, Baylor College of Medicine, CHI St. Luke's Health, Texas, City of Houston Fire Department, The Methodist Hospital Research Institute, West University Fire Department, City of Bellaire Fire Department, Ben Taub Hospital, Harris Health, Patient-Centered Outcomes Research Institute
- Study start
- Aug 2014 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Aug 2023 (estimated)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
There are many ways that use of a MSU might prove valuable in stroke patients, but we will focus on acute ischemic stroke (AIS) and treatment with IV tissue plasminogen activator (tPA) within 4.5 hours of symptom onset since that is the most evidence based effective emergency treatment for the most prevalent stroke diagnosis. We hypothesize that the MSU pathway will result in an overall shift towards earlier evaluation and treatment, particularly into the first hour after symptom onset, leading to substantially better outcome. We also hypothesize that as a result of improved clinical outcomes resulting from earlier treatment, the costs of a MSU program will be offset by a reduction in the costs of long term stroke care and increase in quality adjusted life years, thereby supporting more widespread use of this technology. To make MSU deployment more practical, we will confirm that a Vascular Neurologist (VN) on board the MSU can be replaced by a remote VN connected to the MSU by telemedicine (TM) thereby reducing manpower requirements and costs.
The successful completion of this project will provide data on important outcomes and costs associated with the use of MSU vs SM in the United States (U.S.) that will help determine the value of integrating MSUs into the pre-hospital environment in this country. Successfully addressing our three Specific Aims (time saved/ complications encountered, utility of TM, and cost effectiveness) will provide critical information that will be needed to determine if and how a subsequent more definitive study should be conducted. We anticipate that emanating from this exploratory study would be a larger multicenter trial carried out in both urban and rural U.S. pre-hospital environments, with treatment orchestrated via TM, and having sufficient power to determine a difference in long term outcome and costs between patients managed on the two pathways, following a study design that will be tested in this exploratory trial. The present study, therefore, is the necessary first step in a process which may dramatically modify the way that acute stroke patients are managed in the U.S.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Stroke Unit Management | Active comparator | Other: Mobile Stroke Unit ManagementAcute ischemic stroke patients treated in the Mobile Stroke Unit |
| Standard Management | No intervention | –Acute ischemic stroke patients receiving standard management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Last seen normal within 4hr 30 min of symptom onset
- History and physical/neurological examination consistent with acute stroke
- No tPA exclusions per guidelines, prior to CT scan or baseline labs
- Informed consent obtained from patient (if competent) or legal representative.
Key exclusion criteria (1 listed)
- -None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Stroke Unit ManagementMobile 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. | Other | Mobile Stroke Unit Management |
Primary outcome
Utility-weighted modified Rankin Scale (uw-mRS) from baseline to 90 days
Time frame: 90 days (+/- 10 days) from date of enrollment
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
Agreement between on scene Vascular Neurologist vs. Remote (Telemedicine) Vascular Neurologist
Time frame: up to 4.5 hours from symptom onset
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.
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)
Time frame: up to 1 year from date of enrollment
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.
6 secondary outcomes
90 day Modified Rankin Score
Time frame: 90 days (+/- 10 days) from date of enrollment
90 day Modified Rankin Score
Time frame: 90 days (+/- 10 days) from date of enrollment
Time from symptom onset to tPA treatment
Time frame: up to 4.5 hours from symptom onset
Time from symptom onset to Endovascular treatment
Time frame: up to 6 hours from symptom onset
Symptomatic intracranial hemorrhage and mortality
Time frame: up to hospital discharge
Stroke mimics
Time frame: up to hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Derived from this study: PubMed 41608799Navi 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 Mar;57(3):633-640. doi: 10.1161/STROKEAHA.125.054326. Epub 2026 Jan 29.
- Derived from this study: PubMed 34496173Grotta 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.
- Derived from this study: PubMed 33449944Yamal 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.
- Derived from this study: PubMed 32295510Czap 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.
- Derived from this study: PubMed 29720439Bowry 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.
- Derived from this study: PubMed 28612680Yamal 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.
- Derived from this study: PubMed 28082671Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C Grotta, MD principal investigator
Memorial Hermann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mobile Stroke Unit Management in people with Acute Ischemic Stroke, run by Memorial Hermann Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility-weighted modified Rankin Scale (uw-mRS) from baseline to 90 days (time frame: 90 days (+/- 10 days) from date of enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02190500, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.