Comparison of 5G-Mobile Stroke Unit With Standard EMS for Acute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 5G Mobile Stroke Unit Management, Standard Management.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Other 5G 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. - Other Standard 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.
Primary outcome measures
- Modified Rankin Scale [Time frame: 90 days (±7 days) from date of enrollment]
Secondary outcome measures (12)
- Proportion of patients achieving mRS 0-1 [Time frame: 90 days (±7 days) from date of enrollment]
- Intravenous Thrombolysis rate（A） [Time frame: up to 4.5 hours from symptom onset]
- Intravenous Thrombolysis rate（B） [Time frame: up to 1 hours from symptom onset]
- Endovascular treatment rate [Time frame: up to 24 hours from symptom onset]
- Diagnosis and treatment times (A) [Time frame: up to 4.5 hours from symptom onset]
- Diagnosis and treatment times (B) [Time frame: up to 4.5 hours from symptom onset]
- Diagnosis and treatment times (C) [Time frame: up to 24 hours from symptom onset]
- Diagnosis and treatment times (D) [Time frame: up to 4.5 hours from symptom onset]
- Diagnosis and treatment times (E) [Time frame: up to 4.5 hours from symptom onset]
- Diagnosis and treatment times (F) [Time frame: up to 24 hours from symptom onset]
- Diagnosis and treatment times (G) [Time frame: up to 24 hours from symptom onset]
- Quality of life（A） [Time frame: 90 days (±7 days) from date of enrollment]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Malignant or other severe primary disease with life expectancy <1 year.
- Participation in other interventional randomized clinical trials within 3 months before enrollment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Emergency Medical Center — Beijing
Identifiers
NCT: NCT06943885 · 2023ZD0503802