HYPER-AI-SCAN: HYPER-acute AI-assisted Sonographic Cerebral Hemorrhage Assessment Network
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Feasibility of standardized transcranial ultrasound acquisition in acute stroke
研究概览
简要总结
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.
详细描述
Stroke is a medical emergency that can be caused either by a blocked blood vessel (ischaemic stroke) or by bleeding inside the brain (haemorrhagic stroke). These two types of stroke require very different treatments, and identifying which one is occurring as quickly as possible is essential.
Currently, the only reliable way to distinguish between these two types of stroke is with a brain scan such as a CT scan. However, CT is not always available immediately, especially in prehospital settings or in hospitals without 24/7 imaging access. As a result, patients may experience delays before receiving the correct treatment.
This study aims to explore whether a simple ultrasound scan of the brain, performed through the skull, can help identify haemorrhagic stroke more quickly. This technique is called transcranial Doppler ultrasound (TCD). It is fast, non-invasive, and uses no radiation.
A total of 500 patients with suspected stroke within 48 hours of symptom onset will be included. After the standard CT scan confirms the diagnosis, each participant will undergo a brief ultrasound scan following a structured protocol.
The ultrasound images will then be used to train and test artificial intelligence (AI) models, which will learn to recognize patterns associated with haemorrhagic stroke. These AI models will compare the ultrasound images with CT results and try to predict whether a bleed is present ("ICH suspected") or not.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Feasibility of standardized transcranial ultrasound acquisition in acute stroke
时间窗: At enrollment time (T0)
Feasibility will be measured as the proportion of patients in whom a diagnostic-quality transcranial ultrasound window is obtained (window quality grade 1 or 2). All examinations will follow the same standardized acquisition protocol, ensuring methodological consistency across operators. Diagnostic window success rate (%) will serve as the primary outcome.
次要结局
- Exam acquisition time under a standardized protocol(At enrollment time (T0))
- Accuracy of AI-based classification of intracerebral haemorrhage using standardized TCD acquisitions(From enrollment to the completion of imaging data collection at 16 months)