NCT06943885

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
952

participants targeted

Target at P75+ for not_applicable

Timeline
38mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Apr 2025Jul 2029

First Submitted

Initial submission to the registry

April 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

April 25, 2025

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

3.4 years

First QC Date

April 17, 2025

Last Update Submit

May 11, 2025

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Modified 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.

    90 days (±7 days) from date of enrollment

Secondary Outcomes (19)

  • 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

  • +14 more secondary outcomes

Study Arms (2)

5G Mobile Stroke Unit Management

EXPERIMENTAL

AIS patients treated in the Mobile Stroke Unit

Other: 5G Mobile Stroke Unit Management

Standard Management

ACTIVE COMPARATOR

AIS patients receiving standard management

Other: Standard Management

Interventions

5G Mobile Stroke Unit ManagementOTHER

5G MSU is a specialized stroke ambulance equipped with point of care lab, CT scanner, Telemedicine, allowing patients to receive intravenous thrombolysis.

5G Mobile Stroke Unit Management
Standard ManagementOTHER

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.

Standard Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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）.
  • Informed consent obtained from patient (if competent) or legal representative.

You may not qualify if:

  • Malignant or other severe primary disease with life expectancy \<1 year.
  • Participation in other interventional randomized clinical trials within 3 months before enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Emergency Medical Center

Beijing, Beijing Municipality, 100031, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Dou Li, MD

    Beijing Emergency Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Zhou, MD

CONTACT

+86 13141020699zhoujie_zj94@163.com

Dou Li, MD

CONTACT

+86 13501084639lidou86@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2025

First Posted

April 24, 2025

Study Start

April 25, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

July 1, 2029

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)