Acute Ischemic Stroke
Conditions
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.
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.
Sponsors
Beijing Emergency Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Intravenous Thrombolysis rate（A） | up to 4.5 hours from symptom onset | Proportion of participants ultimately treated with Intravenous Thrombolysis（IVT）within 4.5 hours |
| Intravenous Thrombolysis rate（B） | up to 1 hours from symptom onset | Proportion of participants ultimately treated with IVT within 60 minutes. |
| Endovascular treatment rate | up to 24 hours from symptom onset | Proportion of participants ultimately treated with Endovascular treatment（EVT） |
| Diagnosis and treatment times (A) | up to 4.5 hours from symptom onset | Onset-to-IVT time |
| Diagnosis and treatment times (B) | up to 4.5 hours from symptom onset | Onset-to-IVT decision time |
| Diagnosis and treatment times (C) | up to 24 hours from symptom onset | Onset-to-EVT time |
| Diagnosis and treatment times (D) | up to 4.5 hours from symptom onset | Alarm-to-IVT time |
| Diagnosis and treatment times (E) | up to 4.5 hours from symptom onset | Alarm-to-IVT decision time |
| Diagnosis and treatment times (F) | up to 24 hours from symptom onset | Alarm-to-EVT time |
| Proportion of patients achieving mRS 0-1 | 90 days (±7 days) from date of enrollment | Excellent functional outcome (Modified Rankin Scale score, mRS 0-1) |
| Quality of life（A） | 90 days (±7 days) from date of enrollment | Assessment with European Quality of Life - 5 Dimensions (EQ-5D) |
| Quality of life（B） | 90 days (±7 days) from date of enrollment | Assessment with Barthel Index |
| Cost-Effectiveness(A) | 12 month (±14 days) from date of enrollment | Cost-Effectiveness as measured by patient Quality-Adjusted Life Year（QALYs） |
| Cost-Effectiveness (B) | up to hospital discharge | Cost-Effectiveness as measured by post-stroke healthcare utilization |
| Rate of symptomatic intracranial hemorrhage（ECASS III） | 36 hours from time of enrollment | The incidence of symptomatic intracranial hemorrhage (sICH) , According to the European Cooperative Acute Stroke Study III |
| In-hospital mortality rate | 7 days (±1 day) /discharge from date of enrollment | Frequency of patients dying within the duration of the hospital stay after admission for stroke |
| All-cause mortality rate | 90 days (±7 days) from date of enrollment | All-cause mortality rate at 90±7 days |
| Rate of stroke mimics and transient ischemic attacks | up to hospital discharge | The incidence of stroke mimics and transient ischemic attacks (TIAs) |
| Diagnosis and treatment times (G) | up to 24 hours from symptom onset | Emergency Department（ED）arrival-to-EVT time |
Countries
China
Contacts
Primary ContactJie Zhou, MD
Backup ContactDou Li, MD
Outcome results
None listed