Comparing 5G Mobile Stroke Units to Standard Emergency Services for Stroke Treatment

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

This study is testing whether using 5G Mobile Stroke Units can help stroke patients get better treatment compared to regular emergency services.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 952 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Emergency Medical Center (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06943885 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of 5G Mobile Stroke Units (MSUs) compared to standard Emergency Medical Services (EMS) in treating acute ischemic stroke patients. It is a multicenter, prospective, open-label, blinded endpoint, week-wise randomized, controlled trial that allocates patients to receive either pre-hospital diagnosis and treatment in a 5G MSU or standard EMS management. The primary outcome is the distribution of modified Rankin Scale scores at three months post-treatment, assessing functional outcomes for patients treated within 4.5 hours of symptom onset. The study aims to determine if the 5G MSU approach can improve patient outcomes and safety in urban and rural areas of China.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who exhibit symptoms consistent with acute ischemic stroke and can be treated within 4.5 hours of symptom onset.

Not a fit: Patients with severe primary diseases that limit life expectancy to less than one year or those participating in other interventional trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved functional outcomes for stroke patients through faster and more effective treatment.

How similar studies have performed: While the concept of Mobile Stroke Units is relatively new, there is limited evidence regarding their advantages over standard EMS, making this study a critical evaluation of a novel approach.

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Emergency Medical Center — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Dou Li, MD — Beijing Emergency Medical Center
• Study coordinator: Jie Zhou, MD

Conditions Acute Ischemic Stroke