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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 952
- Locations
- 1
- Primary Endpoint
- Modified Rankin Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •History and physical/neurological examination consistent with acute stroke.
- •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 Criteria
- •Malignant or other severe primary disease with life expectancy <1 year.
- •Participation in other interventional randomized clinical trials within 3 months before enrollment.
Arms & Interventions
5G Mobile Stroke Unit Management
AIS patients treated in the Mobile Stroke Unit
Intervention: 5G Mobile Stroke Unit Management (Other)
Standard Management
AIS patients receiving standard management
Intervention: Standard Management (Other)
Outcomes
Primary Outcomes
Modified Rankin Scale
Time Frame: 90 days (±7 days) from date of enrollment
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.
Secondary Outcomes
- Cost-Effectiveness (B)(up to hospital discharge)
- Proportion of patients achieving mRS 0-1(90 days (±7 days) from date of enrollment)
- Intravenous Thrombolysis rate（A）(up to 4.5 hours from symptom onset)
- Intravenous Thrombolysis rate（B）(up to 1 hours from symptom onset)
- Endovascular treatment rate(up to 24 hours from symptom onset)
- Diagnosis and treatment times (A)(up to 4.5 hours from symptom onset)
- Diagnosis and treatment times (B)(up to 4.5 hours from symptom onset)
- Diagnosis and treatment times (C)(up to 24 hours from symptom onset)
- Diagnosis and treatment times (D)(up to 4.5 hours from symptom onset)
- Diagnosis and treatment times (E)(up to 4.5 hours from symptom onset)
- Diagnosis and treatment times (F)(up to 24 hours from symptom onset)
- Diagnosis and treatment times (G)(up to 24 hours from symptom onset)
- Quality of life（A）(90 days (±7 days) from date of enrollment)
- Quality of life（B）(90 days (±7 days) from date of enrollment)
- Cost-Effectiveness(A)(12 month (±14 days) from date of enrollment)
- Rate of symptomatic intracranial hemorrhage（ECASS III）(36 hours from time of enrollment)
- In-hospital mortality rate(7 days (±1 day) /discharge from date of enrollment)
- All-cause mortality rate(90 days (±7 days) from date of enrollment)
- Rate of stroke mimics and transient ischemic attacks(up to hospital discharge)
Investigators
Dou Li
Principal Investigator
Beijing Emergency Medical Center