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AI-Powered ultrasound aims to speed stroke diagnosis

NCT ID NCT07319013

Knowledge-focused Sponsor: Hospital Universitari Vall d'Hebron Research Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a non-invasive ultrasound scan, combined with artificial intelligence (AI), can quickly identify bleeding in the brain (intracerebral hemorrhage) in people having a stroke. Researchers will enroll 500 adults with acute stroke and perform a standard CT scan plus an extra ultrasound. The AI will learn to distinguish bleeding strokes from non-bleeding ones by comparing its predictions to the CT results. No new treatments are involved; the goal is to see if this approach could lead to faster, more accessible diagnosis in the future.

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 500 people

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

Started

Mar 2025

Expected to finish

Jun 2027

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 consists of adult patients (≥18 years) presenting with suspected acute stroke, either ischaemic or intracerebral haemorrhage. All participants undergo standard-of-care CT imaging to confirm diagnosis. Only supratentorial strokes are included, as patients with infratentorial haemorrhage or isolated subarachnoid haemorrhage are excluded. Eligible patients must be able to undergo transtemporal transcranial Doppler ultrasound using a standardized acquisition protocol. The cohort includes both EMS-transported and in-hospital stroke cases. Participants represent a typical real-world acute stroke population, including individuals with varying stroke severity, vascular risk factors, and clinical profiles. No modifications to clinical management occur as part of the study. Ultrasound acquisition and data collection are purely observational and performed after CT confirmation.

Ages

18 years and older

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: * Adult patients (age ≥18 years). * Clinical diagnosis of acute stroke (ischemic or intracerebral hemorrhage). * Able to undergo transtemporal transcranial ultrasound according to the standardized protocol (no clinical instability) * Informed consent obtained from the patient or legally authorized representative, per local regulations. Exclusion Criteria: * Infratentorial hemorrhage (e.g., cerebellar or brainstem hemorrhage), due to limitations of transtemporal insonation. * Isolated subarachnoid hemorrhage without parenchymal involvement. * Hemodynamic instability or medical conditions requiring immediate life-saving intervention that preclude safe ultrasound recording. * Known skull defects or prior craniectomy on the side required for contralateral insonation. * Any condition that, in the opinion of the investigators, would interfere with protocol adherence or data accuracy.

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Conditions

The condition(s) this trial relates to.

Hemorrhagic Stroke intracerebral hemorrhage ischemic stroke stroke disorder

As listed by the trial registrant

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

Intracerebral haemorrhage Intracerebral hemorrhage Intracerebral hemorrhage basal ganglia Stroke

How to take part

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

  1. The places running it

    1 site. 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

  • Hospital Universitario Vall D'Hebron

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

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