Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06943885

Comparison of 5G-Mobile Stroke Unit With Standard EMS for Acute Ischemic Stroke

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Malignant or other severe primary disease with life expectancy <1 year.
  • Participation in other interventional randomized clinical trials within 3 months before enrollment.

Treatment and study plan

5G Mobile Stroke Unit Management

Other

5G MSU is a specialized stroke ambulance equipped with point of care lab, CT scanner, Telemedicine, allowing patients to receive intravenous thrombolysis.

Standard management

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Proportion of patients achieving mRS 0-1

    Time frame: 90 days (±7 days) from date of enrollment

    Excellent functional outcome (Modified Rankin Scale score, mRS 0-1)

  2. Intravenous Thrombolysis rate（A）

    Time frame: up to 4.5 hours from symptom onset

    Proportion of participants ultimately treated with Intravenous Thrombolysis（IVT）within 4.5 hours

  3. Intravenous Thrombolysis rate（B）

    Time frame: up to 1 hours from symptom onset

    Proportion of participants ultimately treated with IVT within 60 minutes.

  4. Endovascular treatment rate

    Time frame: up to 24 hours from symptom onset

    Proportion of participants ultimately treated with Endovascular treatment（EVT）

  5. Diagnosis and treatment times (A)

    Time frame: up to 4.5 hours from symptom onset

    Onset-to-IVT time

  6. Diagnosis and treatment times (B)

    Time frame: up to 4.5 hours from symptom onset

    Onset-to-IVT decision time

  7. Diagnosis and treatment times (C)

    Time frame: up to 24 hours from symptom onset

    Onset-to-EVT time

  8. Diagnosis and treatment times (D)

    Time frame: up to 4.5 hours from symptom onset

    Alarm-to-IVT time

  9. Diagnosis and treatment times (E)

    Time frame: up to 4.5 hours from symptom onset

    Alarm-to-IVT decision time

  10. Diagnosis and treatment times (F)

    Time frame: up to 24 hours from symptom onset

    Alarm-to-EVT time

  11. Diagnosis and treatment times (G)

    Time frame: up to 24 hours from symptom onset

    Emergency Department（ED）arrival-to-EVT time

  12. Quality of life（A）

    Time frame: 90 days (±7 days) from date of enrollment

    Assessment with European Quality of Life - 5 Dimensions (EQ-5D)

  13. Quality of life（B）

    Time frame: 90 days (±7 days) from date of enrollment

    Assessment with Barthel Index

  14. Cost-Effectiveness(A)

    Time frame: 12 month (±14 days) from date of enrollment

    Cost-Effectiveness as measured by patient Quality-Adjusted Life Year（QALYs）

  15. Cost-Effectiveness (B)

    Time frame: up to hospital discharge

    Cost-Effectiveness as measured by post-stroke healthcare utilization

  16. Rate of symptomatic intracranial hemorrhage（ECASS III）

    Time frame: 36 hours from time of enrollment

    The incidence of symptomatic intracranial hemorrhage (sICH) , According to the European Cooperative Acute Stroke Study III

  17. In-hospital mortality rate

    Time frame: 7 days (±1 day) /discharge from date of enrollment

    Frequency of patients dying within the duration of the hospital stay after admission for stroke

  18. All-cause mortality rate

    Time frame: 90 days (±7 days) from date of enrollment

    All-cause mortality rate at 90±7 days

  19. Rate of stroke mimics and transient ischemic attacks

    Time frame: up to hospital discharge

    The incidence of stroke mimics and transient ischemic attacks (TIAs)

Study contacts

Contact information is provided by the study sponsor or research team.

Dou Li, MD

CONTACT

[email protected]

+86 13501084639

Jie Zhou, MD

CONTACT

[email protected]

+86 13141020699

Sponsors and collaborators

Lead sponsor

Beijing Emergency Medical Center

Other

Registry information

Official study 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

Acronym: 5G-MSU-FAST

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 24, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.