RECRUITINGOBSERVATIONAL

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

HYPER-AI-SCAN: HYPER-acute AI-assisted Sonographic Cerebral Hemorrhage Assessment Network

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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) - willing to sign a consent form obtained from the patient or legally authorized representative, per local regulations. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Locations (1)

Hospital Universitario Vall D'Hebron

Barcelona, Catalonia, Spain