HYPER-AI-SCAN Using AI-Assisted Transcranial Ultrasound to Detect Brain Bleeds in Acute Stroke Patients
Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2026-01-06
500
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating whether combining transcranial Doppler ultrasound with artificial intelligence AI can help detect intracerebral hemorrhage ICH in adults with acute stroke within 48 hours of symptom onset. The study focuses on the feasibility of performing standardized ultrasound scans in stroke patients and whether AI can accurately distinguish hemorrhagic stroke from non-hemorrhagic stroke by comparing ultrasound predictions with CT scan results, which are the standard diagnostic method.
Participants will undergo a standard CT scan to confirm stroke type, followed by a non-invasive transcranial Doppler ultrasound scan using a structured protocol. The ultrasound images will be coded and used to train and test AI models designed to recognize patterns linked to hemorrhagic stroke. No treatments or changes to clinical care are introduced as part of this observational research.
During the study, participants will provide clinical and imaging information collected as part of routine care, while researchers will evaluate the feasibility of ultrasound acquisition and the accuracy of AI-based classification. The main outcome is the ability to perform standardized ultrasound scans, with secondary measures including exam acquisition time and AI accuracy. The ultrasound is performed only for research and does not affect participants treatment. The study aims to improve early stroke diagnosis, especially where CT is not immediately available.
CONDITIONS
Brief Title
AI-assisted Transcranial Duplex Sonography for Early Detection of Intracerebral Haemorrhage: HYPER-AI-SCAN
Research Team
R
RENATO SIMONETTI, MD
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Hospital Universitari Vall d'Hebron Research Institute
Lead Sponsor
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Adult patients (age �3e�3d 18 years)
Clinical diagnosis of acute stroke (ischemic or intracerebral hemorrhage)
Able to undergo transtemporal transcranial ultrasound following standardized protocol
Informed consent obtained from patient or legally authorized representative
You will not qualify if you...
Infratentorial hemorrhage such as cerebellar or brainstem hemorrhage
Isolated subarachnoid hemorrhage without brain tissue involvement
Hemodynamic instability or urgent medical conditions preventing safe ultrasound
Known skull defects or prior craniectomy on the ultrasound side
Any condition that may interfere with following the study protocol or affect data accuracy
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Within 48 hours of symptom onset
Participants undergo a standard CT scan to confirm the type of stroke, followed by a research transcranial Doppler ultrasound (TCD) performed using a standardized protocol for study purposes.
1 visit (in-person) at enrollment
Long-term Monitoring
Duration - Up to 16 months
Data from ultrasound images and CT results are used to train and evaluate AI models over the study period without affecting clinical care.
No additional visits required for this study phase
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Feasibility of an AI-assisted transcranial duplex sonography protocol for early detection of intracerebral haemorrhage: the HYPER-AI-SCAN single-centre prospective study.
Renato Simonetti, Pere Canals, Jesus David Gonzalez Riveros...