StrokeNCT07319013
AI-assisted Transcranial Duplex Sonography for Early Detection of Intracerebral Haemorrhage: HYPER-AI-SCAN
An observational study of Stroke and Intracerebral Hemorrhage, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
The goal of this observational study is to evaluate whether transcranial Doppler ultrasound, combined with artificial intelligence (AI), can help identify intracerebral haemorrhage (ICH) in people with acute stroke (both men and women, adults of all ages) within 48 hours of symptom onset. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Intracerebral Hemorrhage, Intracerebral Hemorrhage Basal Ganglia
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 14 Mar 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Vall D'Hebron
Barcelona, Catalonia, 08035
RENATO SIMONETTI, MD, +34934893000 ext. 6660, renato.simonetti@vallhebron.cat
About this study
Official title: HYPER-AI-SCAN: HYPER-acute AI-assisted Sonographic Cerebral Hemorrhage Assessment Network
The goal of this observational study is to evaluate whether transcranial Doppler ultrasound, combined with artificial intelligence (AI), can help identify intracerebral haemorrhage (ICH) in people with acute stroke (both men and women, adults of all ages) within 48 hours of symptom onset.
The main questions it aims to answer are:
Read more
Is it feasible to perform standardized protocol transcranial ultrasound in acute stroke patients? Can AI models trained on ultrasound images accurately distinguish haemorrhagic stroke ("ICH suspected") from non-haemorrhagic stroke? There is no comparison group, because all participants will undergo both CT (as standard care) and ultrasound (research imaging), and the AI models will compare their ultrasound-based predictions against CT-confirmed diagnoses.
Participants will:
undergo a non-invasive transcranial ultrasound scan after CT confirms the type of stroke allow researchers to collect coded ultrasound images for AI model training provide clinical and imaging information (already collected as part of routine care) to help evaluate factors related to diagnostic accuracy No treatments or changes to clinical care will be introduced as part of the study.
Read the detailed description
Stroke is a medical emergency that can be caused either by a blocked blood vessel (ischaemic stroke) or by bleeding inside the brain (haemorrhagic stroke). These two types of stroke require very different treatments, and identifying which one is occurring as quickly as possible is essential.
Currently, the only reliable way to distinguish between these two types of stroke is with a brain scan such as a CT scan. However, CT is not always available immediately, especially in prehospital settings or in hospitals without 24/7 imaging access. As a result, patients may experience delays before receiving the correct treatment.
This study aims to explore whether a simple ultrasound scan of the brain, performed through the skull, can help identify haemorrhagic stroke more quickly. This technique is called transcranial Doppler ultrasound (TCD). It is fast, non-invasive, and uses no radiation.
A total of 500 patients with suspected stroke within 48 hours of symptom onset will be included. After the standard CT scan confirms the diagnosis, each participant will undergo a brief ultrasound scan following a structured protocol.
The ultrasound images will then be used to train and test artificial intelligence (AI) models, which will learn to recognize patterns associated with haemorrhagic stroke. These AI models will compare the ultrasound images with CT results and try to predict whether a bleed is present ("ICH suspected") or not.
The main goals of the study are:
To determine whether portable ultrasound can be performed reliably and consistently in real stroke patients.
To evaluate whether AI can support clinicians by interpreting these ultrasound images and distinguishing between haemorrhagic and non-haemorrhagic strokes.
All other clinical information-such as symptoms, timing of arrival, and medical history-will also be collected to understand which factors may influence the performance of ultrasound and AI.
Importantly, the ultrasound does not replace standard medical care and will not influence the treatment that patients receive. It is performed only for research purposes. The CT scan remains the reference test for diagnosis.
By combining ultrasound with AI, this project hopes to pave the way for future systems capable of assisting paramedics or physicians in identifying haemorrhagic stroke earlier, especially in settings where CT is not immediately available. Earlier recognition may help reduce delays in blood pressure management or treatment reversal for patients taking anticoagulants.
- Conditions
- Stroke, Intracerebral Hemorrhage, Intracerebral Hemorrhage Basal Ganglia, Intracerebral Haemorrhage
- Keywords
- stroke, intracerebral hemorrage, Ischemic Stroke, Hemorrhagic Stroke, transcranial ultrasound, Transcranial Doppler, Portable Ultrasound, Neurosonology, Artificial Intelligence, Machine Learning, Diagnostic Accuracy, Prehospital Care, Feasibility Study, Deep Learning
- Medical subject headings
- Stroke, Cerebral Hemorrhage, Ischemic Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute stroke patients | Single cohort of adults with suspected acute stroke (<48 hours from symptom onset), including both ischaemic and intracerebral haemorrhagic stroke. All participants will undergo standard diagnostic evaluation with computed tomography (CT). A research transcranial Doppler ultrasound (TCD) examination will then be performed using a standardized acquisition protocol. Coded sonographic data will be used to train and evaluate artificial intelligence (AI) models for the classification of intracerebral haemorrhage ("ICH suspected" vs. "No ICH"). No intervention or change in clinical management is introduced as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of standardized transcranial ultrasound acquisition in acute stroke
Feasibility will be measured as the proportion of patients in whom a diagnostic-quality transcranial ultrasound window is obtained (window quality grade 1 or 2). All examinations will follow the same standardized acquisition protocol, ensuring methodological consistency across operators. Diagnostic window success rate (%) will serve as the primary outcome.
Measured: At enrollment time (T0)
Secondary outcomes (2)
Exam acquisition time under a standardized protocol
Time (in seconds) from probe placement to acquisition of the first diagnostic-quality sonographic frame, obtained using the standardized sonographic protocol. Results will be reported as median, interquartile range (IQR), and distribution.
Measured: At enrollment time (T0)
Accuracy of AI-based classification of intracerebral haemorrhage using standardized TCD acquisitions
Evaluation of artificial intelligence models (CNN and transformer-based architectures) trained on ultrasound images acquired with a uniform standardized protocol. Performance will be assessed against CT-confirmed diagnosis.
Measured: From enrollment to the completion of imaging data collection at 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start14 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319013
- Sponsor's protocol ID
- PR(AG)015/2025
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because the study collects sensitive clinical and imaging information, and no formal data-sharing agreements or secure access frameworks are currently in place. Sharing policies may be reconsidered if a structured multicenter collaboration with appropriate data protections is established.
Publications
Simonetti R, Canals P, Gonzalez Riveros JD, Alanis-Bernal M, Pancorbo O, Rodriguez-Luna D. Feasibility of an AI-assisted transcranial duplex sonography protocol for early detection of intracerebral haemorrhage: the HYPER-AI-SCAN single-centre prospective study. BMJ Open. 2025 Nov 19;15(11):e102903. doi: 10.1136/bmjopen-2025-102903.
PubMed 41263848
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYPER-AI-SCAN: HYPER-acute AI-assisted Sonographic Cerebral Hemorrhage Assessment Network
- ClinicalTrials.gov ID
- NCT07319013
- Acronym / sponsor ID
- PR(AG)015/2025
- Conditions
- Stroke, Intracerebral Hemorrhage, Intracerebral Hemorrhage Basal Ganglia, Intracerebral Haemorrhage
- Keywords
- stroke, intracerebral hemorrage, Ischemic Stroke, Hemorrhagic Stroke, transcranial ultrasound, Transcranial Doppler, Portable Ultrasound, Neurosonology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Jan 2026 (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.
The goal of this observational study is to evaluate whether transcranial Doppler ultrasound, combined with artificial intelligence (AI), can help identify intracerebral haemorrhage (ICH) in people with acute stroke (both men and women, adults of all ages) within 48 hours of symptom onset.
The main questions it aims to answer are:
Is it feasible to perform standardized protocol transcranial ultrasound in acute stroke patients? Can AI models trained on ultrasound images accurately distinguish haemorrhagic stroke ("ICH suspected") from non-haemorrhagic stroke? There is no comparison group, because all participants will undergo both CT (as standard care) and ultrasound (research imaging), and the AI models will compare their ultrasound-based predictions against CT-confirmed diagnoses.
Participants will:
undergo a non-invasive transcranial ultrasound scan after CT confirms the type of stroke allow researchers to collect coded ultrasound images for AI model training provide clinical and imaging information (already collected as part of routine care) to help evaluate factors related to diagnostic accuracy No treatments or changes to clinical care will be introduced as part of the study.
Detailed description
Stroke is a medical emergency that can be caused either by a blocked blood vessel (ischaemic stroke) or by bleeding inside the brain (haemorrhagic stroke). These two types of stroke require very different treatments, and identifying which one is occurring as quickly as possible is essential.
Currently, the only reliable way to distinguish between these two types of stroke is with a brain scan such as a CT scan. However, CT is not always available immediately, especially in prehospital settings or in hospitals without 24/7 imaging access. As a result, patients may experience delays before receiving the correct treatment.
This study aims to explore whether a simple ultrasound scan of the brain, performed through the skull, can help identify haemorrhagic stroke more quickly. This technique is called transcranial Doppler ultrasound (TCD). It is fast, non-invasive, and uses no radiation.
A total of 500 patients with suspected stroke within 48 hours of symptom onset will be included. After the standard CT scan confirms the diagnosis, each participant will undergo a brief ultrasound scan following a structured protocol.
The ultrasound images will then be used to train and test artificial intelligence (AI) models, which will learn to recognize patterns associated with haemorrhagic stroke. These AI models will compare the ultrasound images with CT results and try to predict whether a bleed is present ("ICH suspected") or not.
The main goals of the study are:
To determine whether portable ultrasound can be performed reliably and consistently in real stroke patients.
To evaluate whether AI can support clinicians by interpreting these ultrasound images and distinguishing between haemorrhagic and non-haemorrhagic strokes.
All other clinical information-such as symptoms, timing of arrival, and medical history-will also be collected to understand which factors may influence the performance of ultrasound and AI.
Importantly, the ultrasound does not replace standard medical care and will not influence the treatment that patients receive. It is performed only for research purposes. The CT scan remains the reference test for diagnosis.
By combining ultrasound with AI, this project hopes to pave the way for future systems capable of assisting paramedics or physicians in identifying haemorrhagic stroke earlier, especially in settings where CT is not immediately available. Earlier recognition may help reduce delays in blood pressure management or treatment reversal for patients taking anticoagulants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute stroke patients | – | –Single cohort of adults with suspected acute stroke (<48 hours from symptom onset), including both ischaemic and intracerebral haemorrhagic stroke. All participants will undergo standard diagnostic evaluation with computed tomography (CT). A research transcranial Doppler ultrasound (TCD) examination will then be performed using a standardized acquisition protocol. Coded sonographic data will be used to train and evaluate artificial intelligence (AI) models for the classification of intracerebral haemorrhage ("ICH suspected" vs. "No ICH"). No intervention or change in clinical management is introduced as part of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of standardized transcranial ultrasound acquisition in acute stroke
Time frame: At enrollment time (T0)
Feasibility will be measured as the proportion of patients in whom a diagnostic-quality transcranial ultrasound window is obtained (window quality grade 1 or 2). All examinations will follow the same standardized acquisition protocol, ensuring methodological consistency across operators. Diagnostic window success rate (%) will serve as the primary outcome.
2 secondary outcomes
Exam acquisition time under a standardized protocol
Time frame: At enrollment time (T0)
Accuracy of AI-based classification of intracerebral haemorrhage using standardized TCD acquisitions
Time frame: From enrollment to the completion of imaging data collection at 16 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Results publication: PubMed 41263848Simonetti R, Canals P, Gonzalez Riveros JD, Alanis-Bernal M, Pancorbo O, Rodriguez-Luna D. Feasibility of an AI-assisted transcranial duplex sonography protocol for early detection of intracerebral haemorrhage: the HYPER-AI-SCAN single-centre prospective study. BMJ Open. 2025 Nov 19;15(11):e102903. doi: 10.1136/bmjopen-2025-102903.
- Individual participant dataSharing planned: No. IPD will not be shared because the study collects sensitive clinical and imaging information, and no formal data-sharing agreements or secure access frameworks are currently in place. Sharing policies may be reconsidered if a structured multicenter collaboration with appropriate data protections is established.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Intracerebral Hemorrhage, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RENATO SIMONETTI, MD (+34934893000 ext. 6660, renato.simonetti@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of standardized transcranial ultrasound acquisition in acute stroke (time frame: At enrollment time (T0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07319013, which also lists 1 linked publication.
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 6 Jan 2026.