AI-assisted Transcranial Duplex Sonography for Early Detection of Intracerebral Haemorrhage: HYPE… (NCT07319013) | Clinical Trial Compass
RecruitingNot Applicable
AI-assisted Transcranial Duplex Sonography for Early Detection of Intracerebral Haemorrhage: HYPER-AI-SCAN
Spain500 participantsStarted 2025-03-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of standardized transcranial ultrasound acquisition in acute stroke
Timeframe: At enrollment time (T0)
Trial details
NCT IDNCT07319013
SponsorHospital Universitari Vall d'Hebron Research Institute