AI-assisted transcranial Doppler ultrasound to detect early brain bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will enroll 500 adults with suspected acute stroke who present within 48 hours of symptom onset at a single center. After the standard CT scan confirms the diagnosis, each participant will undergo a structured transtemporal transcranial Doppler ultrasound and images will be coded for research. Collected ultrasound images will be used to train and test AI models that predict whether intracerebral hemorrhage is present by comparing AI output to CT-confirmed diagnoses. There is no treatment intervention; the goal is to determine whether standardized ultrasound acquisition and AI interpretation can reliably flag haemorrhagic versus non-haemorrhagic strokes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario Vall D'Hebron
  Barcelona, Catalonia, Spain Recruiting

Study contacts

• Study coordinator: Renato Simonetti, Md
• Email: renato.simonetti@vallhebron.cat
• Phone: +34934893000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.