Actively Recruiting

Age: 18Years +
All Genders
NCT07319013

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

Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2026-01-06

500

Participants Needed

1

Research Sites

115 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients (age �3e=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
Not Eligible

You will not qualify if you...

  • 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 would interfere with protocol adherence or data accuracy in the opinion of the investigators

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital Universitario Vall D'Hebron

Barcelona, Catalonia, Spain, 08035

Actively Recruiting

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Research Team

R

RENATO SIMONETTI, MD

CONTACT

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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