AI-Driven Health Management to Prevent Ischemic Stroke in High-Risk Adults
ConditionIschemic Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorXuanwu Hospital, Beijing
About this trial
This study will evaluate whether an artificial intelligence (AI)-driven dynamic health management strategy can help prevent ischemic stroke in adults at high risk of stroke. Participants will be identified through community-based screening in Beijing using the AI-ExpoStroke model together with established stroke risk factors.
Communities will be randomly assigned to either an AI-driven health management group or a usual community-based health management group. Participants in the AI-driven group will receive continuous health management supported by a digital platform, mobile applications or WeChat-based tools, wearable-device data when available, personalized health guidance, and remote support from community health care providers. Participants in the usual-care group will receive routine community health services, including health examinations, health education, chronic disease follow-up, and medication guidance.
Participants will be followed for 36 months. The main goal is to determine whether AI-driven health management reduces the occurrence of first-ever ischemic stroke. The study will also evaluate transient ischemic attacks, stroke-related disability, mortality, control of major vascular risk factors, adherence to health management, and health economic outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 30 years or older, with no restriction on sex.
Permanent resident of Beijing.
No previously diagnosed stroke based on prospective community screening.
Identified as being at high risk of stroke by the AI-ExpoStroke model in combination with the established stroke "8+2" high-risk factors.
Disqualifiers
Previous diagnosis of ischemic stroke or hemorrhagic stroke.
Severe cognitive impairment.
Severe organic disease, including malignant tumors, New York Heart Association (NYHA) class III or higher heart failure, renal failure, or other severe conditions.
Psychiatric or language impairment that prevents completion of study questionnaires or follow-up.
Trial design
Design model
Parallel
Treatments tested in this trial
Usual Community-Based Health Management
Other interventionUsual community-based health management for adults at high risk of stroke, including routine health examinations, basic health education, standard chronic disease follow-up, and routine medication guidance according to community health care practice. Participants do not receive the AI-driven dynamic health management service provided through the AI-ExpoStroke platform.
AI-Driven Dynamic Health Management
Other interventionA comprehensive AI-supported health management strategy for adults at high risk of stroke. The intervention integrates the AI-ExpoStroke risk assessment system with a digital stroke prevention and management platform, mobile applications or WeChat-based tools, wearable-device interfaces when applicable, and coordinated community health care. Participants generally report blood pressure, body weight, medication use, and lifestyle-related information at least monthly. The platform supports dynamic risk assessment, individualized risk-factor management targets, health reminders, lifestyle recommendations, health education, and remote guidance from community health care providers. AI-generated recommendations are intended to support health management and do not replace clinical decision-making by physicians.
Treatment groups
26,000 Participants
are divided into 2 treatment groupsGroup A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
3-Year Cumulative Incidence of First-Ever Ischemic Stroke
The proportion of participants who experience a first-ever ischemic stroke during the 36-month follow-up period. Ischemic stroke will be confirmed based on clinical symptoms and signs together with neuroimaging evidence, including computed tomography or magnetic resonance imaging, according to the predefined endpoint adjudication process.
Time frame
From randomization through 36 monthsSecondary outcomes
1
Cumulative Incidence of First-Ever Transient Ischemic Attack
The proportion of participants who experience a first-ever transient ischemic attack (TIA) during the follow-up period, based on clinical evaluation and relevant medical records according to the predefined endpoint adjudication process.
Time frame
From randomization through 36 months2
Proportion of Participants With Disability Following Incident Stroke
The proportion of participants with an incident stroke who are assessed as having stroke-related disability during follow-up. Disability status will be evaluated at endpoint assessment, and the modified Rankin Scale (mRS) will be recorded for participants with stroke-related disability.
Time frame
From randomization through 36 months3
All-Cause Mortality
The proportion of participants who die from any cause during the 36-month follow-up period. Deaths will be verified using available medical records, discharge summaries, death certificates, or other relevant records.
Time frame
From randomization through 36 months4
Cardiovascular and Cerebrovascular Mortality
The proportion of participants who die from cardiovascular or cerebrovascular causes during the 36-month follow-up period. Cause of death will be determined using available clinical records and the predefined endpoint adjudication process.
Time frame
From randomization through 36 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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