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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Universitario Vall D'Hebron
RECRUITING
Barcelona
Contact Information
Primary
RENATO SIMONETTI, MD
renato.simonetti@vallhebron.cat
+34934893000
Time Frame
Start Date: 2025-03-14
Estimated Completion Date: 2027-06
Participants
Target number of participants: 500
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Hospital Universitari Vall d'Hebron Research Institute

This content was sourced from clinicaltrials.gov