Clinical trial NCT06804707: Carotid Plaque Characterization Using Innovative Ultrasound Techniques
Official title: Tissue and Vascular Microstructure Evaluation for Carotid Plaque Characterization Using Innovative Ultrasound Techniques
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carotid Atheroma
Keywords: Carotid atheroma
Plaque characterization
Ultrasound
Ultrasound Localization Microscopy
Backscatter Coefficient
Vasa vasorum
Intraplaque Hemorrhage
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-center, cross-sectional, descriptive and exploratory study.
Primary purpose: BASIC_SCIENCE

Brief summary: Strokes are the second leading cause of disability and death worldwide (according to World Health Organization in 2019). They are ischemic in origin in 80% of cases. Atheromatous disease, and more specifically carotid stenosis, is responsible for 20% of these ischemic strokes. Current recommendations, based on high levels of evidence, consider only the degree of carotid artery stenosis to define the threshold for surgical treatment. However, it is now accepted that the composition and rate of progression of atherosclerotic plaque are also criteria to be considered when selecting patients at high risk of stroke. The presence of hemorrhage and a lipid core in the atheromatous plaque, both factors of instability, is associated with a greater risk of ipsilateral ischemic events. The presence of intraplaque hemorrhage is therefore a marker of plaque instability. In this context, techniques for in vivo analysis of atherosclerotic plaque composition need to be developed to better target patients for surgery.

Ultrafast ultrasound enables imaging rates of several thousand images per second. Ultrasound Localization Microscopy (ULM) gives access to the vascular microstructure of tissues: the localization of injected microbubbles, which enhance the ultrasound signal in vessels, and the tracking of these microbubbles enable the vascularization of the tissue in question to be mapped. Ultrasound spectroscopy qualifies tissue microstructure: this operator- and system-independent technique is based on frequency analysis of ultrasound signals backscattered by tissue, and more specifically on analysis of the backscatter coefficient (BSC). Measuring the BSC is intrinsic to the tissue, and provides quantitative parameters on the scatterers to qualify the tissue.

The study hypothesis is that these two ultrasound techniques will provide information on the characteristics of the atherosclerotic plaque: the presence of neovessels and biomarkers linked to its composition, including intraplaque hemorrhage.


Eligibility criteria: Inclusion Criteria:

* Female or male over 18 years of age
* Patients with asymptomatic or symptomatic carotid plaque (stenosis\> 50% NASCET), referred by the Hospices Civils de Lyon (HCL) vascular surgery consultation and for whom a surgical indication has been retained.
* Patient having agreed to participate in the study and signed a written informed consent form
* Patient affiliated to a social security scheme or equivalent.

Exclusion Criteria:

* Patients with contraindications to Sonovue (right-to-left shunt, severe pulmonary hypertension, allergy to the molecule)
* Patients with unstable cardiovascular pathology (coronary artery disease, stroke / transient ischemic attack, cardiac rhythm disorders)
* Uncontrolled hypertension
* Respiratory distress syndrome
* Patients with contraindications to MRI (claustrophobia, presence of metallic elements, etc.).
* Gadolinium-related contraindications and precautions for use
* Contraindication to dobutamine
* Hypersensitivity to the active substance or to one of the constituents of Gadolinium,
* Renal insufficiency with clearance \<30 ml/min/1.73 m²,
* Pregnant or breast-feeding patients
* Patients under guardianship or trusteeship

Primary outcomes:
measure: Volume of neovessels in carotid atherosclerotic plaques by ULM
timeFrame: between 6 and 59 days after inclusion
measure: Mean velocity in neovessels in carotid atherosclerotic plaques by ULM
timeFrame: between 6 and 59 days after inclusion
measure: Location of neovessels in carotid atherosclerotic plaques by ULM
timeFrame: between 6 and 59 days after inclusion
Secondary outcomes:
measure: Lizzi Feleppa slope (dB/MHz) derived from BSC measured by ultrasound spectroscopy on carotid atherosclerotic plaques
timeFrame: between 6 and 59 days after inclusion
measure: Lizzi Feleppa intercept (dB) derived from BSC measured by ultrasound spectroscopy on carotid atherosclerotic plaques
timeFrame: between 6 and 59 days after inclusion
measure: Lizzi Feleppa midband (dB) derived from BSC measured by ultrasound spectroscopy on carotid atherosclerotic plaques
timeFrame: between 6 and 59 days after inclusion
measure: Integrated backscatter coefficient (BSC) (dB) measured by ultrasound spectroscopy on carotid atherosclerotic plaques
timeFrame: between 6 and 59 days after inclusion
measure: Acoustic attenuation (dB/mm) measured by ultrasound on carotid atherosclerotic plaques
timeFrame: between 6 and 59 days after inclusion
measure: Correlation between the volume of neovessels in carotid atherosclerotic plaques, estimated by ULM, and that estimated by anatomopathological analyses
timeFrame: between 6 and 59 days after inclusion
measure: Correlation between ultrasound parameters of BSC related to intraplaque hemorrhage of carotid atherosclerotic plaques and intraplaque hemorrhage assessed by anatomopathological analyses
timeFrame: between 6 and 59 days after inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Dr Ariane BLEROT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: