Pilot Study of the Characterization of Subacute Ischemic Cerebrovascular Accidents in the Region of the Middle Cerebral Artery by 3D Ultrasound Localization Microscopy (ULM) with a Research Ultrasound System and Non-marketed 2D Matrix Probe.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators
研究概览
简要总结
The goal of this proof of concept study is to determine if the visualization of the middle cerebral artery and its perforators, through 3D transtemporal ultrasound imaging, is possible thanks to an off-line analysis by 3D ultrasound localization microscopy. Visualization of these vessels would allow us to conclude on the presence, or absence, of an ischemic stroke in the region of the middle cerebral artery.
To answer the question asked, 20 participants who suffered a stroke will carry out a transtemporal ultrasound examination specifically for research in the 7 days following his stroke. The data obtained will be analyzed by the CNRS medical imaging laboratory, in order to characterize the presence of a stroke and to compare the data obtained with that of standard examinations (CT and MRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patient aged 18 and over
- •Hospitalized patient with ischemic stroke in the deep territory of the middle cerebral artery
- •Patient with lesion observable on MRI
- •Patient included between 24 hours and 7 days after the ischemic stroke
- •Patient with a temporal window which allows soundproofing of the polygon of Willis and the middle cerebral artery
- •Patient having signed free, informed and written consent
- •Patient affiliated to a social security system (excluding AME)
排除标准
- •Contralateral middle cerebral artery territory stroke or contralateral middle cerebral artery occlusion
- •Patient with contraindication to Doppler ultrasound with contrast (right-left shunt, severe pulmonary arterial hypertension)
- •Patient with hypersensitivity to the active princip of Sonovue (sulfur hexafluoride) or these excipients
- •Patient with uncontrolled systemic hypertension
- •Patient with respiratory distress syndrome
- •Patient under guardianship or curatorship
- •Pregnant or breastfeeding patient (positive blood pregnancy test during hospitalization)
- •Patient with damaged skin at the temporal level
- •Patient having presented in the 7 days preceding inclusion an acute coronary syndrome or suffering from unstable ischemic heart disease
结局指标
主要结局
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators
时间窗: Day 1
Measure of the caliber of visible vessels (mm)
次要结局
- Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)(Day 1)