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AI could spot hidden stroke type that often worsens quickly

NCT ID NCT07693816

Diagnosis Sponsor: Peking Union Medical College Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study is developing and testing an artificial intelligence (AI) model to help diagnose a specific type of stroke called branch atheromatous disease (BAD)-related stroke. BAD strokes are hard to identify because symptoms are not specific, and diagnosis requires combining clinical and imaging information. The AI will analyze routine medical data and brain scans from 1,602 adults who had a stroke within the past week. The goal is to see if the AI can accurately tell BAD strokes apart from other strokes, which could lead to earlier and more appropriate care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Multisource clinical-imaging artificial intelligence diagnostic assessment
What this could lead to
If successful, this AI tool could help doctors quickly and accurately diagnose a stroke subtype that is often missed, potentially leading to faster, more appropriate treatment.
What could go wrong
This is an observational study to develop and validate the model, not a treatment trial. The AI may not perform well enough in real-world settings, and it does not directly improve patient outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,602 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include adults aged 18 to 80 years with acute ischemic stroke who present within 1 week after symptom onset or last known well time at participating stroke centers. Participants will be classified as BAD-related stroke or non-BAD acute ischemic stroke according to predefined diagnostic criteria and independent central clinical-imaging adjudication.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 to 80 years. * Diagnosis of acute ischemic stroke. * Time from symptom onset to enrollment ≤ 1 week; if the onset time is unknown, time from last known well to enrollment ≤ 1 week. * Availability of required baseline clinical and neuroimaging assessments according to the study protocol. * Written informed consent provided by the participant or legally authorized representative. Participants will be classified into the BAD-related stroke cohort if they meet all predefined BAD-related stroke diagnostic criteria, including: * A single isolated deep subcortical infarct on diffusion-weighted imaging. * The presumed culprit perforating artery is the lenticulostriate artery or the paramedian pontine artery. * For lenticulostriate artery territory infarction: a comma-shaped lesion extending from inferior to superior direction on coronal DWI or involvement of ≥3 axial DWI slices with 5-7 mm slice thickness. * For paramedian pontine artery territory infarction: a lesion extending from the deep pons to the ventral surface of the pons on axial DWI. * No ≥50% stenosis of the corresponding parent artery, confirmed by MRA, CTA, or DSA. Participants with acute ischemic stroke who do not meet BAD-related stroke criteria will be classified into the non-BAD acute ischemic stroke cohort. Exclusion Criteria: General exclusion criteria for all participants: * Intracranial hemorrhage, vascular malformation, aneurysm, brain abscess, malignant intracranial mass, or other non-ischemic intracranial lesion on baseline CT, MRI, MRA, CTA, or DSA. * Pre-stroke modified Rankin Scale score ≥2. * Life expectancy ≤6 months. * Unable to tolerate MRI examination. * Pregnancy or breastfeeding. * Participation in another clinical study within 3 months before informed consent or current participation in another clinical study that may interfere with this study. Additional criteria that preclude classification as BAD-related stroke: * Ipsilateral extracranial tandem artery stenosis ≥50%. * Definite cardioembolic source, including atrial fibrillation, myocardial infarction, clinically significant valvular heart disease, dilated cardiomyopathy, infective endocarditis, atrioventricular conduction disease, or heart rate \<50 beats/min as defined in the protocol. * Receipt of or planned acute-phase endovascular treatment after stroke onset. * Stroke due to other determined causes, such as moyamoya disease, arterial dissection, or vasculitis.

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Conditions

The condition(s) this trial relates to.

atherosclerosis cerebral infarction ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke Branch atheromatous disease Cerebral infarction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Fangshan District Liangxiang Hospital

    RECRUITING

    Beijing, China

  • Beijing Haidian Hospital

    RECRUITING

    Beijing, China

  • Beijing Huaxin Hospital (The First Hospital of Tsinghua University)

    RECRUITING

    Beijing, China

  • Beijing Jingmei Group General Hospital

    RECRUITING

    Beijing, China

  • Beijing Longfu Hospital

    RECRUITING

    Beijing, China

  • Beijing Puren Hospital

    RECRUITING

    Beijing, China

  • Beijing Shijingshan Hospital

    RECRUITING

    Beijing, China

  • Beijing Shijitan Hospital, Capital Medical University

    RECRUITING

    Beijing, China

  • Beijing Sixth Hospital

    RECRUITING

    Beijing, China

  • Beijing Yanqing District Hospital

    RECRUITING

    Beijing, China

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, China

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