Acute Ischemic Strokei-PathNCT06613074
Ali Pay Intelligent Navigation Applet-aided Pre-hospital Triage for Non-emergency Medical Service Patients With Acute Ischemic Stroke
A study testing Ali Pay intelligent navigation applet in people with Acute Ischemic Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Ali Pay intelligent navigation applet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed as acute ischemic stroke undergoing reperfusion therapy within 24 hours of onset
Who cannot join
- Patients transported to hospitals via emergency medical service
- Patients with in-hospital stroke
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shaoxing People's Hospital
Shaoxing, Zhejing, 312000
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Ali Pay intelligent navigation applet
- Keywords
- reperfusion therapy, pre-hospital triage
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ali Pay intelligent navigation appletDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified rankin scale (mRS) scores of 0-2 at 90 days after reperfusion therapy
Measured: 90 days
Secondary outcomes (7)
Modified rankin scale (mRS) scores of 0-1 at 90 days after reperfusion therapy
Measured: 90 days
Modified rankin scale (mRS) scores of 0-3 at 90 days after reperfusion therapy
Measured: 90 days
Ordinal analysis of modified rankin scale (mRS) scores at 90 days after reperfusion therapy
Measured: 90 days
Time interval between onset to treatment
Measured: 1 day
Time interval between onset to hospital
Measured: 1 day
Proportion of patients receiving reperfusion beyond time window
Intravenous thrombolysis: treatment initiated within 4.5 - 9 hours after onset Mechanical thrombectomy: treatment initiated within 6 - 24 hours after onset
Measured: 1 day
Proportion of patients receiving mechanical thrombectomy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Apr 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Lou, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613074
- Sponsor's protocol ID
- i-Path
- Acronym
- i-Path
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06613074
- Acronym / sponsor ID
- i-Path / i-Path
- Conditions
- Acute Ischemic Stroke
- Keywords
- reperfusion therapy, pre-hospital triage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed as acute ischemic stroke undergoing reperfusion therapy within 24 hours of onset
Key exclusion criteria (2 listed)
- Patients transported to hospitals via emergency medical service
- Patients with in-hospital stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ali Pay intelligent navigation appletThe 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 | Device | – |
Primary outcome
Modified rankin scale (mRS) scores of 0-2 at 90 days after reperfusion therapy
Time frame: 90 days
7 secondary outcomes
Modified rankin scale (mRS) scores of 0-1 at 90 days after reperfusion therapy
Time frame: 90 days
Modified rankin scale (mRS) scores of 0-3 at 90 days after reperfusion therapy
Time frame: 90 days
Ordinal analysis of modified rankin scale (mRS) scores at 90 days after reperfusion therapy
Time frame: 90 days
Time interval between onset to treatment
Time frame: 1 day
Time interval between onset to hospital
Time frame: 1 day
Proportion of patients receiving reperfusion beyond time window
Time frame: 1 day
Proportion of patients receiving mechanical thrombectomy
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ali Pay intelligent navigation applet in people with Acute Ischemic Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Lou, PhD, MD (86057187783777, lm99@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified rankin scale (mRS) scores of 0-2 at 90 days after reperfusion therapy (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.