Comparison of 5G-Mobile Stroke Unit With Standard EMS for Acute Ischemic Stroke (5G-MSU-FAST)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Other: 5G Mobile Stroke Unit Management; Other: Standard Management

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 Type: Interventional
• Enrollment (Estimated): 952
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Zhou, MD; Phone Number: +86 13141020699; Email: zhoujie_zj94@163.com
• Study Contact Backup: Name: Dou Li, MD; Phone Number: +86 13501084639; Email: lidou86@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100031
      • Recruiting
      • Beijing Emergency Medical Center
      • Contact: Jie Zhou, MD; Phone Number: +86 13141020699; Email: zhoujie_zj94@163.com
      • Contact: Dou Li, MD; Phone Number: +86 13501084639; Email: lidou86@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. History and physical/neurological examination consistent with acute stroke.
2. Age≥18.
3. Last seen normal within 4hr 30 min of symptom onset.
4. Pre-stroke modified Rankin scale ≤3（Being able to ambulate）.
5. No rt-PA/TNK exclusions per guidelines, prior to CT scan or baseline labs.
6. Informed consent obtained from patient (if competent) or legal representative.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5G Mobile Stroke Unit Management; AIS patients treated in the Mobile Stroke Unit	Other: 5G Mobile Stroke Unit Management; 5G MSU is a specialized stroke ambulance equipped with point of care lab, CT scanner, Telemedicine, allowing patients to receive intravenous thrombolysis.
Active Comparator: Standard Management; AIS patients receiving standard management	Other: Standard Management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days (±7 days) from date of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients achieving mRS 0-1	Excellent functional outcome (Modified Rankin Scale score, mRS 0-1)	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	up to 4.5 hours from symptom onset
Intravenous Thrombolysis rate（B）	Proportion of participants ultimately treated with IVT within 60 minutes.	up to 1 hours from symptom onset
Endovascular treatment rate	Proportion of participants ultimately treated with Endovascular treatment（EVT）	up to 24 hours from symptom onset
Diagnosis and treatment times (A)	Onset-to-IVT time	up to 4.5 hours from symptom onset
Diagnosis and treatment times (B)	Onset-to-IVT decision time	up to 4.5 hours from symptom onset
Diagnosis and treatment times (C)	Onset-to-EVT time	up to 24 hours from symptom onset
Diagnosis and treatment times (D)	Alarm-to-IVT time	up to 4.5 hours from symptom onset
Diagnosis and treatment times (E)	Alarm-to-IVT decision time	up to 4.5 hours from symptom onset
Diagnosis and treatment times (F)	Alarm-to-EVT time	up to 24 hours from symptom onset
Diagnosis and treatment times (G)	Emergency Department（ED）arrival-to-EVT time	up to 24 hours from symptom onset
Quality of life（A）	Assessment with European Quality of Life - 5 Dimensions (EQ-5D)	90 days (±7 days) from date of enrollment
Quality of life（B）	Assessment with Barthel Index	90 days (±7 days) from date of enrollment
Cost-Effectiveness(A)	Cost-Effectiveness as measured by patient Quality-Adjusted Life Year（QALYs）	12 month (±14 days) from date of enrollment
Cost-Effectiveness (B)	Cost-Effectiveness as measured by post-stroke healthcare utilization	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	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	7 days (±1 day) /discharge from date of enrollment
All-cause mortality rate	All-cause mortality rate at 90±7 days	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)	up to hospital discharge

Collaborators and Investigators

• Sponsor: Beijing Emergency Medical Center
• Investigators: Principal Investigator: Dou Li, MD, Beijing Emergency Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: April 17, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 11, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Ischemic Stroke; Stroke; Cerebral Infarction; Ischemia
• Other Study ID Numbers: 2023ZD0503802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No