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

Beijing Emergency Medical Center

Status: Enrolling

Conditions: Acute Ischemic Stroke

Treatments: Other: 5G Mobile Stroke Unit Management; Other: Standard Management

Study type: Interventional

Funder types: Other

Identifiers

NCT06943885

2023ZD0503802

Details and patient eligibility

About

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.

Full 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.

Enrollment: 952 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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952 participants in 2 patient groups

5G Mobile Stroke Unit Management

Experimental group

Description:

AIS patients treated in the Mobile Stroke Unit

Treatment:

Other: 5G Mobile Stroke Unit Management

Standard Management

Active Comparator group

Description:

AIS patients receiving standard management

Treatment:

Other: Standard Management