NCT06613074

Brief Summary

According to the Bigdata Observatory platform for Stroke of China (BOSC), the proportion of patients with acute ischemic stroke (AIS) receiving intravenous thrombolysis or endovascular treatment in China is 5.64% and 1.45% respectively. One of the important reasons for the low treatment rate is the prolonged pre-hospital and in-hospital delay. Besides, for patients receiving reperfusion therapy, the prolonged pre-treatment delay is associated with unfavorable functional outcomes. Although tons of efforts have been made to improve the efficiency of emergency medical system in the transportation of patients with AIS, little attention has been paid to patients who arrived at hospitals on their owns, which occupying approximately 2/3 of emergency patients. This leaves a huge gap in the pre-hospital management of patietns with AIS. Therefore, the investigators plan to develop an intelligent navigation system for patients with AIS. For the convenience of public use, this system was carried on the applet of Ali Pay, which has over 1.1 billion users in China. This system comprises of three functional modules, namely stroke knowledge education, stroke recognition and hospital recommendation. The investigators aim to explore whether this intelligent navigatino system could shorten pre-hospital delay and improve functional outcomes of patients with AIS undergoing reperfusion therapy.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

August 8, 2025

Status Verified

September 1, 2024

Enrollment Period

1.1 years

First QC Date

September 23, 2024

Last Update Submit

August 6, 2025

Conditions

Keywords

reperfusion therapypre-hospital triage

Outcome Measures

Primary Outcomes (1)

  • Modified rankin scale (mRS) scores of 0-2 at 90 days after reperfusion therapy

    90 days

Secondary Outcomes (7)

  • Modified rankin scale (mRS) scores of 0-1 at 90 days after reperfusion therapy

    90 days

  • Modified rankin scale (mRS) scores of 0-3 at 90 days after reperfusion therapy

    90 days

  • Ordinal analysis of modified rankin scale (mRS) scores at 90 days after reperfusion therapy

    90 days

  • Time interval between onset to treatment

    1 day

  • Time interval between onset to hospital

    1 day

  • +2 more secondary outcomes

Study Arms (2)

Ali Pay intelligent navigation applet group

EXPERIMENTAL

Patients in regions with Ali Pay intelligent navigation applet being released would be classified as experimental arm. In this arm, patients have access to this applet. The intelligent navigation applet comprises of three function modules: 1. Stroke knowledge public education: information regarding prevention and emergency treatment of stroke would be push to users' mobile phones regularly; 2. Stroke recognition: questionaires, voice interaction, and facial recognition are employed to identify patients with AIS and large vessel occlusion; 3. Hospital recommendation: this module combines real-time traffic and average in-hopital delay of each stroke center nearby, recommending the stroke center in which patients are mostly likely to receive reperfusion therapy

Routine pre-hospital triage

NO INTERVENTION

Patients in regions without Ali Pay intelligent navigation applet being released would be classified as control arm. In this arm, patients do not have access to this applet.

Interventions

The intelligent navigation applet comprises of three function modules: 1. Stroke knowledge public education: information regarding prevention and emergency treatment of stroke would be push to users\' mobile phones regularly; 2. Stroke recognition: questionaires, voice interaction, and facial recognition are employed to identify patients with AIS and large vessel occlusion; 3. Hospital recommendation: this module combines real-time traffic and average in-hopital delay of each stroke center nearby, recommending the stroke center in which patients are mostly likely to receive reperfusion therapy

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed as acute ischemic stroke undergoing reperfusion therapy within 24 hours of onset

You may not qualify if:

  • Patients transported to hospitals via emergency medical service
  • Patients with in-hospital stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaoxing People's Hospital

Shaoxing, Zhejing, 312000, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Min Lou, PhD, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

September 23, 2024

First Posted

September 25, 2024

Study Start

April 1, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

August 8, 2025

Record last verified: 2024-09

Locations