NCT07319013Recruiting
AI-assisted Transcranial Duplex Sonography for Early Detection of Intracerebral Haemorrhage: HYPER-AI-SCAN
HYPER-AI-SCAN: HYPER-acute AI-assisted Sonographic Cerebral Hemorrhage Assessment Network
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 7 Dec 2025
- Start date
- 14 Mar 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Diseases
- Stroke
- NCT number
- NCT07319013
What you commit to
- Study type: Observational
- Planned participants: 500
- From 14 Mar 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known skull defects or prior craniectomy on the side required for contralateral insonation.
Other illness
- 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.
- Any condition that, in the opinion of the investigators, would interfere with protocol adherence or data accuracy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.