Not yet recruiting NA INTERVENTIONAL NCT07779668

Can AI-driven health management prevent stroke? — 26,000 adults followed for 36 months, randomized by community (Beijing, NCT07779668)

Xuanwu Hospital, Beijing Updated 2026-09-02

An interventional trial that identifies adults at high risk of stroke through community screening and randomizes communities to AI-driven health management or usual community-based health management. Planned enrollment is 26,000 with 36 months of follow-up, and the main goal is whether first-ever ischemic stroke can be reduced.

Trial overview (primary data)

  • StatusNot yet recruiting
  • ConditionsIschemic Stroke
  • InterventionsOTHER: Usual Community-Based Health Management, OTHER: AI-Driven Dynamic Health Management
  • SponsorXuanwu Hospital, Beijing
  • Target enrollment26,000 participants
  • Period2026-08-31 〜 2029-12-31

Key points

  • High-risk adults are identified through community screening using the AI-ExpoStroke model together with established stroke risk factors.
  • The unit of assignment is the community, not the individual, comparing AI-driven health management against usual community-based health management.
  • The main goal is whether first-ever ischemic stroke can be reduced, with 36 months of follow-up.
  • Secondary evaluation covers transient ischemic attacks, stroke-related disability, mortality, vascular risk-factor control, adherence, and health economic outcomes.
  • The planned enrollment of 26,000 is 130 times the median planned enrollment of 200 across the 750 medical-AI trials this site holds as of 2026-08-28.
  • It measures whether strokes decrease over 36 months rather than AI accuracy, randomising by community rather than individual.

1Trials that measure accuracy, and trials that measure onset

Most medical-AI trials measure how well an AI can tell things apart. That is not what this one sets out to measure. It asks whether putting an AI-supported health-management system into communities actually reduces strokes — the outcome itself. Better image reading does not lower incidence if blood pressure and medication do not hold in daily life.

The design is an attempt to cross the long distance between a prediction and an event, using 36 months of follow-up.

2Randomizing communities rather than individuals

That the unit of assignment is the community rather than the individual says a great deal about the character of the design. Health guidance and encouragement spread easily to those nearby, and mixing intervention and control participants in one community lets the effects bleed into each other.

Splitting by community avoids that contamination, and by implication it means the intervention is conceived as the operation of community health services rather than as a prescription to an individual. Wearable data is explicitly limited to when it is available, so the design does not assume that devices will be distributed.

3Among the largest medical-AI trials this site holds

Across the 750 medical-AI clinical trials this site holds as of 2026-08-28, the median planned enrollment is 200. The 26,000 planned here is 130 times that median. Only 50 trials — 6.7 percent — plan 5,000 or more, while 254 trials, or 34 percent, plan 100 or fewer. In that distribution this one stands out sharply.

Clinical evaluation of medical AI is dominated by small accuracy studies, and a trial that goes after incidence at scale is exceptional. What the AI-ExpoStroke model contains, and whether strokes are in fact reduced, are not part of this registry record.

4Trials that measure accuracy, and trials that measure incidence

Most medical AI trials measure how correctly the AI distinguishes. What this trial measures is the outcome itself.

A trial measuring accuracyA trial measuring incidence (this trial)
Asks how correctly the AI distinguishesAsks whether strokes decrease
Produces a result relatively quicklyRequires 36 months of follow-up
Randomised at the individual levelRandomised by community
Can be evaluated on image-reading performanceTurns on whether blood pressure control and medication continue in daily life

That randomisation is by community rather than by individual also marks the design. Health guidance and outreach spread easily to those nearby, and mixing intervention and control within one community lets the effects bleed. It means the intervention is conceived not as a prescription to an individual but as the operation of community health itself.

Why it matters

The accuracy of a predictive model and whether incidence actually falls are separate questions. Randomizing by community with incidence as the main goal offers one answer to how the effect of an AI-supported health service should be tested.

FAQ

Why randomize by community?
Health guidance and encouragement spread easily to those nearby, so mixing intervention and control participants in one community lets the effects bleed into each other. Splitting by community avoids that contamination.
Will every participant receive a wearable device?
No. The record states that wearable-device data is used when available. The design does not assume that devices will be distributed.
Has AI been shown to reduce strokes?
No. The trial is recorded as not yet recruiting, so no results exist. What is described here is the aim and the design.

Sources (primary)

Source: ClinicalTrials.gov (U.S. NIH/NLM, public domain). This site does not provide medical advice. Verify the latest and exact details with the official source. This site is not endorsed or certified by the NIH/NLM.

#Clinical trials#AI#Healthcare#Stroke#Public health
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