Acute Ischemic Stroke5G-MSU-FASTNCT06943885
Comparison of 5G-Mobile Stroke Unit With Standard EMS for Acute Ischemic Stroke
A study testing 5G Mobile Stroke Unit Management and Standard Management in people with Acute Ischemic Stroke, run by Beijing Emergency Medical Center at 1 site in China.
Trial summary
While Mobile Stroke Units (MSUs) are considered as a relatively new model for acute stroke treatment, 5G Mobile Stroke Units (5G MSUs) have already come into service for stroke treatment in some parts of China. 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?
- 5G Mobile Stroke Unit Management and Standard Management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 952 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2025to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- History and physical/neurological examination consistent with acute stroke.
- Age≥18.
- Last seen normal within 4hr 30 min of symptom onset.
- Pre-stroke modified Rankin scale ≤3（Being able to ambulate）.
- No rt-PA/TNK exclusions per guidelines, prior to CT scan or baseline labs.
- Informed consent obtained from patient (if competent) or legal representative.
Who cannot join
- Malignant or other severe primary disease with life expectancy <1 year.
- Participation in other interventional randomized clinical trials within 3 months before enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Emergency Medical Center
Beijing, Beijing Municipality, 100031
Jie Zhou, MD, +86 13141020699, zhoujie_zj94@163.com
Dou Li, MD, +86 13501084639, lidou86@126.com
About this study
Official title: Comparison of 5G Mobile Stroke Unit to Standard Management by Emergency Medical Services For Acute Ischemic Stroke Treatment：A Multicenter, Prospective, Open-label, Blinded Endpoint , Week-wise Randomized, Controlled Trial
While Mobile Stroke Units (MSUs) are considered as a relatively new model for acute stroke treatment, 5G Mobile Stroke Units (5G MSUs) have already come into service for stroke treatment in some parts of China. Since limited evidence has been found to suggest their advantages over conventional Emergency Medical Services (EMS), well-conducted clinical studies are required to further assess their effectiveness and safety. This study aims to evaluate whether 5G MSUs outperform standard management (SM) by EMS in terms of functional outcomes of acute ischemic stroke (AIS) patients within 4.5 hours after symptom onset in urban and rural areas of China.
Read the detailed description
This Multicenter, Prospective, Open-label, Blinded Endpoint , Week-wise Randomized, Controlled trial will allocate patients to one of two study arms for the analyses：one group will receive pre-hospital diagnosis and treatment in a 5G MSU followed by transfer to a Comprehensive Stroke Center (CSC) Emergency Department (ED) for further management; the other group will undergo standard pre-hospital triage with subsequent transport by EMS to a CSC ED for evaluation and treatment. The main criteria to enroll a patient into the study include: a. history and physical/neurological examination consistent with acute stroke, b. age≥18, c. last seen normal within 4hr 30 min of symptom onset, d. pre-stroke modified Rankin scale ≤3 (Being able to ambulate), e. no Recombinant tissue Plasminogen Activator（rt-PA）or Tenecteplase（TNK）exclusions per guidelines, prior to CT scan or baseline labs and f. informed consent obtained from patient (if competent) or legal representative. The primary outcome was the distribution of modified Rankin Scale (mRS) scores (a disability score ranging from 0, no neurological deficits, to 6, death) at 3 months.
It is hypothesized that the 5G MSU pathway, compared to EMS, can enable earlier evaluation and treatment of AIS patients within 4.5 hours of onset, thereby improving functional outcomes three months after stroke while ensuring safety. The successful completion of this project will provide data on important outcomes and costs associated with the use of 5G MSU vs SM in China that will help determine the value of integrating 5G MSUs into the pre-hospital environment in this country.
- Conditions
- Acute Ischemic Stroke
- Being tested
- 5G Mobile Stroke Unit Management, Standard Management
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5G Mobile Stroke Unit ManagementOther
5G MSU is a specialized stroke ambulance equipped with point of care lab, CT scanner, Telemedicine, allowing patients to receive intravenous thrombolysis.
Standard ManagementOther
A regular ambulance. The standard management by EMS includes Electrocardiographic（ECG）monitoring, blood glucose management, airway, respiration, and blood pressure control, complication management, intravenous access establishment and other emergency measures.
| Study group | Role | What they receive |
|---|---|---|
| 5G Mobile Stroke Unit Management | Experimental | AIS patients treated in the Mobile Stroke Unit Receives: Other: 5G Mobile Stroke Unit Management |
| Standard Management | Active comparator | AIS patients receiving standard management Receives: Other: Standard Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale
Assessment of functional outcome using the Modified Rankin Scale (mRS), a disability scale that ranges from 0 (no symptoms) to 6 (death), with higher scores indicating worse functional outcomes.
Measured: 90 days (±7 days) from date of enrollment
Secondary outcomes (19)
Proportion of patients achieving mRS 0-1
Excellent functional outcome (Modified Rankin Scale score, mRS 0-1)
Measured: 90 days (±7 days) from date of enrollment
Intravenous Thrombolysis rate（A）
Proportion of participants ultimately treated with Intravenous Thrombolysis（IVT）within 4.5 hours
Measured: up to 4.5 hours from symptom onset
Intravenous Thrombolysis rate（B）
Proportion of participants ultimately treated with IVT within 60 minutes.
Measured: up to 1 hours from symptom onset
Endovascular treatment rate
Proportion of participants ultimately treated with Endovascular treatment（EVT）
Measured: up to 24 hours from symptom onset
Diagnosis and treatment times (A)
Onset-to-IVT time
Measured: up to 4.5 hours from symptom onset
Diagnosis and treatment times (B)
Onset-to-IVT decision time
Measured: up to 4.5 hours from symptom onset
Diagnosis and treatment times (C)
Onset-to-EVT time
Measured: up to 24 hours from symptom onset
Diagnosis and treatment times (D)
Alarm-to-IVT time
Measured: up to 4.5 hours from symptom onset
Diagnosis and treatment times (E)
Alarm-to-IVT decision time
Measured: up to 4.5 hours from symptom onset
Diagnosis and treatment times (F)
Alarm-to-EVT time
Measured: up to 24 hours from symptom onset
Diagnosis and treatment times (G)
Emergency Department（ED）arrival-to-EVT time
Measured: up to 24 hours from symptom onset
Quality of life（A）
Assessment with European Quality of Life - 5 Dimensions (EQ-5D)
Measured: 90 days (±7 days) from date of enrollment
Quality of life（B）
Assessment with Barthel Index
Measured: 90 days (±7 days) from date of enrollment
Cost-Effectiveness(A)
Cost-Effectiveness as measured by patient Quality-Adjusted Life Year（QALYs）
Measured: 12 month (±14 days) from date of enrollment
Cost-Effectiveness (B)
Cost-Effectiveness as measured by post-stroke healthcare utilization
Measured: up to hospital discharge
Rate of symptomatic intracranial hemorrhage（ECASS III）
The incidence of symptomatic intracranial hemorrhage (sICH) , According to the European Cooperative Acute Stroke Study III
Measured: 36 hours from time of enrollment
In-hospital mortality rate
Frequency of patients dying within the duration of the hospital stay after admission for stroke
Measured: 7 days (±1 day) /discharge from date of enrollment
All-cause mortality rate
All-cause mortality rate at 90±7 days
Measured: 90 days (±7 days) from date of enrollment
Rate of stroke mimics and transient ischemic attacks
The incidence of stroke mimics and transient ischemic attacks (TIAs)
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 posted24 Apr 2025
- Study start25 Apr 2025
- Primary completionOct 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 952 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Emergency Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dou Li, Beijing Emergency Medical Center
- Investigators
- Dou Li, MD, Principal investigator, Beijing Emergency Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943885
- Sponsor's protocol ID
- 2023ZD0503802
- Acronym
- 5G-MSU-FAST
- Status last verified
- May 2025
- First submitted
- 17 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 5G Mobile Stroke Unit to Standard Management by Emergency Medical Services For Acute Ischemic Stroke Treatment：A Multicenter, Prospective, Open-label, Blinded Endpoint , Week-wise Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06943885
- Acronym / sponsor ID
- 5G-MSU-FAST / 2023ZD0503802
- Conditions
- Acute Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 952 participants (estimated)
- Lead sponsor
- Beijing Emergency Medical CenterUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 24 Apr 2025 (actual)
- 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.
While Mobile Stroke Units (MSUs) are considered as a relatively new model for acute stroke treatment, 5G Mobile Stroke Units (5G MSUs) have already come into service for stroke treatment in some parts of China. Since limited evidence has been found to suggest their advantages over conventional Emergency Medical Services (EMS), well-conducted clinical studies are required to further assess their effectiveness and safety. This study aims to evaluate whether 5G MSUs outperform standard management (SM) by EMS in terms of functional outcomes of acute ischemic stroke (AIS) patients within 4.5 hours after symptom onset in urban and rural areas of China.
Detailed description
This Multicenter, Prospective, Open-label, Blinded Endpoint , Week-wise Randomized, Controlled trial will allocate patients to one of two study arms for the analyses：one group will receive pre-hospital diagnosis and treatment in a 5G MSU followed by transfer to a Comprehensive Stroke Center (CSC) Emergency Department (ED) for further management; the other group will undergo standard pre-hospital triage with subsequent transport by EMS to a CSC ED for evaluation and treatment. The main criteria to enroll a patient into the study include: a. history and physical/neurological examination consistent with acute stroke, b. age≥18, c. last seen normal within 4hr 30 min of symptom onset, d. pre-stroke modified Rankin scale ≤3 (Being able to ambulate), e. no Recombinant tissue Plasminogen Activator（rt-PA）or Tenecteplase（TNK）exclusions per guidelines, prior to CT scan or baseline labs and f. informed consent obtained from patient (if competent) or legal representative. The primary outcome was the distribution of modified Rankin Scale (mRS) scores (a disability score ranging from 0, no neurological deficits, to 6, death) at 3 months.
It is hypothesized that the 5G MSU pathway, compared to EMS, can enable earlier evaluation and treatment of AIS patients within 4.5 hours of onset, thereby improving functional outcomes three months after stroke while ensuring safety. The successful completion of this project will provide data on important outcomes and costs associated with the use of 5G MSU vs SM in China that will help determine the value of integrating 5G MSUs into the pre-hospital environment in this country.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5G Mobile Stroke Unit Management | Experimental | Other: 5G Mobile Stroke Unit ManagementAIS patients treated in the Mobile Stroke Unit |
| Standard Management | Active comparator | Other: Standard ManagementAIS 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 (6 listed)
- History and physical/neurological examination consistent with acute stroke.
- Age≥18.
- Last seen normal within 4hr 30 min of symptom onset.
- Pre-stroke modified Rankin scale ≤3（Being able to ambulate）.
- No rt-PA/TNK exclusions per guidelines, prior to CT scan or baseline labs.
Key exclusion criteria (2 listed)
- Malignant or other severe primary disease with life expectancy <1 year.
- Participation in other interventional randomized clinical trials within 3 months before enrollment.
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 |
|---|---|---|
| 5G Mobile Stroke Unit Management5G MSU is a specialized stroke ambulance equipped with point of care lab, CT scanner, Telemedicine, allowing patients to receive intravenous thrombolysis. | Other | 5G Mobile Stroke Unit Management |
| Standard ManagementA regular ambulance. The standard management by EMS includes Electrocardiographic（ECG）monitoring, blood glucose management, airway, respiration, and blood pressure control, complication management, intravenous access establishment and other emergency measures. | Other | Standard Management |
Primary outcome
Modified Rankin Scale
Time frame: 90 days (±7 days) from date of enrollment
Assessment of functional outcome using the Modified Rankin Scale (mRS), a disability scale that ranges from 0 (no symptoms) to 6 (death), with higher scores indicating worse functional outcomes.
19 secondary outcomes
Proportion of patients achieving mRS 0-1
Time frame: 90 days (±7 days) from date of enrollment
Intravenous Thrombolysis rate（A）
Time frame: up to 4.5 hours from symptom onset
Intravenous Thrombolysis rate（B）
Time frame: up to 1 hours from symptom onset
Endovascular treatment rate
Time frame: up to 24 hours from symptom onset
Diagnosis and treatment times (A)
Time frame: up to 4.5 hours from symptom onset
Diagnosis and treatment times (B)
Time frame: up to 4.5 hours from symptom onset
Diagnosis and treatment times (C)
Time frame: up to 24 hours from symptom onset
Diagnosis and treatment times (D)
Time frame: up to 4.5 hours from symptom onset
Diagnosis and treatment times (E)
Time frame: up to 4.5 hours from symptom onset
Diagnosis and treatment times (F)
Time frame: up to 24 hours from symptom onset
Diagnosis and treatment times (G)
Time frame: up to 24 hours from symptom onset
Quality of life（A）
Time frame: 90 days (±7 days) from date of enrollment
Quality of life（B）
Time frame: 90 days (±7 days) from date of enrollment
Cost-Effectiveness(A)
Time frame: 12 month (±14 days) from date of enrollment
Cost-Effectiveness (B)
Time frame: up to hospital discharge
Rate of symptomatic intracranial hemorrhage（ECASS III）
Time frame: 36 hours from time of enrollment
In-hospital mortality rate
Time frame: 7 days (±1 day) /discharge from date of enrollment
All-cause mortality rate
Time frame: 90 days (±7 days) from date of enrollment
Rate of stroke mimics and transient ischemic attacks
Time frame: up to hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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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.
Dou Li, MD principal investigator
Beijing Emergency Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5G Mobile Stroke Unit Management and Standard Management in people with Acute Ischemic Stroke, run by Beijing Emergency Medical Center at 1 site in China.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 May 2025. 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 China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Zhou, MD (+86 13141020699, zhoujie_zj94@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (time frame: 90 days (±7 days) from date of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2025.