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NCT Number: NCT06613074

Ali Pay Intelligent Navigation Applet-aided Pre-hospital Triage for Non-emergency Medical Service Patients With Acute Ischemic Stroke

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaoxing People's Hospital

Shaoxing, Zhejing, 312000, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ali Pay intelligent navigation applet

Device

The intelligent navigation applet comprises of three function modules:

  • Stroke knowledge public education: information regarding prevention and emergency treatment of stroke would be push to users' mobile phones regularly;
  • Stroke recognition: questionaires, voice interaction, and facial recognition are employed to identify patients with AIS and large vessel occlusion;
  • 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

Primary outcomes

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

    Time frame: 90 days

Secondary outcomes

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

    Time frame: 90 days

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

    Time frame: 90 days

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

    Time frame: 90 days

  4. Time interval between onset to treatment

    Time frame: 1 day

  5. Time interval between onset to hospital

    Time frame: 1 day

  6. Proportion of patients receiving reperfusion beyond time window

    Time frame: 1 day

    Intravenous thrombolysis: treatment initiated within 4.5 - 9 hours after onset Mechanical thrombectomy: treatment initiated within 6 - 24 hours after onset

  7. Proportion of patients receiving mechanical thrombectomy

    Time frame: 1 day

Study contacts

Contact information is provided by the study sponsor or research team.

Min Lou, PhD, MD

CONTACT

[email protected]

86057187783777

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Ali Pay Intelligent Navigation Applet-aided Pre-hospital Triage for Non-emergency Medical Service Patients With Acute Ischemic Stroke: A Step-wedge Cluster Randomized Controlled Trial

Acronym: i-Path

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2024
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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