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.
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.
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.
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.
Cohort
Prospective
Not listed
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.
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.
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.
Operator-level variability in acquisition performance using the standardized protocol
Comparison of diagnostic level images acquisition time across operators performing scans with the same standardized protocol. Results will evaluate reproducibility and ease of training.
Operator-level variability in acquisition performance using the standardized protocol
Comparison of transtemporal window acquisition success rate across operators performing scans with the same standardized protocol. Results will evaluate reproducibility and ease of training.
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