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

NCT ID: NCT06943885

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 952 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-25
• Study Completion Date: 2029-07-31

Brief 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. 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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

5G Mobile Stroke Unit Management

AIS patients treated in the Mobile Stroke Unit

Group Type: EXPERIMENTAL

5G Mobile Stroke Unit Management

Intervention Type: 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

AIS patients receiving standard management

Group Type: ACTIVE_COMPARATOR

Standard Management

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Emergency Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dou Li

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dou Li, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Emergency Medical Center

Locations

Beijing Emergency Medical Center

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jie Zhou, MD

Role: CONTACT

zhoujie_zj94@163.com

+86 13141020699

Dou Li, MD

Role: CONTACT

lidou86@126.com

+86 13501084639

Facility Contacts

Jie Zhou, MD

Role: primary

zhoujie_zj94@163.com

+86 13141020699

Dou Li, MD

Role: backup

lidou86@126.com

+86 13501084639

Other Identifiers

2023ZD0503802

Identifier Type: -

Identifier Source: org_study_id