AI-assisted Transcranial Duplex Sonography for Early Detection of Intracerebral Haemorrhage: HYPER-AI-SCAN

NCT07319013 | Recruiting

• 1 other identifier: PR(AG)015/2025
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Intracerebral Hemorrhage; Intracerebral Haemorrhage; Intracerebral Hemorrhage Basal Ganglia

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

Outcome Measures

Primary Outcomes (1)

• 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.

  At enrollment time (T0)

Secondary Outcomes (2)

• Exam acquisition time under a standardized protocol

  At enrollment time (T0)

• Accuracy of AI-based classification of intracerebral haemorrhage using standardized TCD acquisitions

  From enrollment to the completion of imaging data collection at 16 months

Other Outcomes (2)

• Operator-level variability in acquisition performance using the standardized protocol

  At enrollment time (T0)

• Operator-level variability in acquisition performance using the standardized protocol

  At enrollment time (T0)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitario Vall D'Hebron

Barcelona, Catalonia, 08035, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 41263848 RESULT

MeSH Terms

Conditions

Stroke; Cerebral Hemorrhage; Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

RENATO SIMONETTI, MD

CONTACT

+34934893000; renato.simonetti@vallhebron.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 6, 2026
• Study Start: March 14, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)