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

Recruitingn/aAges 18 Years - anyAllHospital Universitari Vall d'Hebron Research Inst…
NCT07319013 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 str

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📋 Eligibility rules (as published)
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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What it tests

  • Not listed
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Where

1 site
Hospital Universitario Vall D'Hebron
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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