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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
952
5G MSU is a specialized stroke ambulance equipped with point of care lab, CT scanner, Telemedicine, allowing patients to receive intravenous thrombolysis.
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.
Beijing Emergency Medical Center
Beijing, Beijing Municipality, China
RECRUITINGModified Rankin Scale
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.
Time frame: 90 days (±7 days) from date of enrollment
Proportion of patients achieving mRS 0-1
Excellent functional outcome (Modified Rankin Scale score, mRS 0-1)
Time frame: 90 days (±7 days) from date of enrollment
Intravenous Thrombolysis rate（A）
Proportion of participants ultimately treated with Intravenous Thrombolysis（IVT）within 4.5 hours
Time frame: up to 4.5 hours from symptom onset
Intravenous Thrombolysis rate（B）
Proportion of participants ultimately treated with IVT within 60 minutes.
Time frame: up to 1 hours from symptom onset
Endovascular treatment rate
Proportion of participants ultimately treated with Endovascular treatment（EVT）
Time frame: up to 24 hours from symptom onset
Diagnosis and treatment times (A)
Onset-to-IVT time
Time frame: up to 4.5 hours from symptom onset
Diagnosis and treatment times (B)
Onset-to-IVT decision time
Time frame: up to 4.5 hours from symptom onset
Diagnosis and treatment times (C)
Onset-to-EVT time
Time frame: up to 24 hours from symptom onset
Diagnosis and treatment times (D)
Alarm-to-IVT time
Time frame: up to 4.5 hours from symptom onset
Diagnosis and treatment times (E)
Alarm-to-IVT decision time
Time frame: up to 4.5 hours from symptom onset
Diagnosis and treatment times (F)
Alarm-to-EVT time
Time frame: up to 24 hours from symptom onset
Diagnosis and treatment times (G)
Emergency Department（ED）arrival-to-EVT time
Time frame: up to 24 hours from symptom onset
Quality of life（A）
Assessment with European Quality of Life - 5 Dimensions (EQ-5D)
Time frame: 90 days (±7 days) from date of enrollment
Quality of life（B）
Assessment with Barthel Index
Time frame: 90 days (±7 days) from date of enrollment
Cost-Effectiveness(A)
Cost-Effectiveness as measured by patient Quality-Adjusted Life Year（QALYs）
Time frame: 12 month (±14 days) from date of enrollment
Cost-Effectiveness (B)
Cost-Effectiveness as measured by post-stroke healthcare utilization
Time frame: up to hospital discharge
Rate of symptomatic intracranial hemorrhage（ECASS III）
The incidence of symptomatic intracranial hemorrhage (sICH) , According to the European Cooperative Acute Stroke Study III
Time frame: 36 hours from time of enrollment
In-hospital mortality rate
Frequency of patients dying within the duration of the hospital stay after admission for stroke
Time frame: 7 days (±1 day) /discharge from date of enrollment
All-cause mortality rate
All-cause mortality rate at 90±7 days
Time frame: 90 days (±7 days) from date of enrollment
Rate of stroke mimics and transient ischemic attacks
The incidence of stroke mimics and transient ischemic attacks (TIAs)
Time frame: up to hospital discharge
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