RecruitingNot ApplicableNCT06943885

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

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

Sponsor

Beijing Emergency Medical Center

Enrollment

952 participants

Start Date

Apr 25, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Ischemic Stroke

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria2

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

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Interventions

OTHER5G 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.

OTHERStandard 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.