Clinical trial NCT06133179: Super-Resolution Ultrasound of the Brain in 3D
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Stroke
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
First posted: 2023-11-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Proof of concept, exploratory, single group, non-comparative, uncontrolled study
Primary purpose: DIAGNOSTIC

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: 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
timeFrame: Day 1
Secondary outcomes:
measure: Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)
timeFrame: Day 1
measure: Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)
timeFrame: Day 1
measure: Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)
timeFrame: Day 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bichat
state: Ile de France
Study officials:
References: