Carotid Plaque Characterization Using Innovative Ultrasound Techniques (CARPUS)

Civil Hospices of Lyon

Status: Not yet enrolling

Conditions: Carotid Atheroma

Treatments: Biological: blood sampling; Device: ultrasound imaging exam; Device: High resolution MRI plaque exam

Study type: Interventional

Funder types: Other

Identifiers

NCT06804707

69HCL24_0689

Details and patient eligibility

About

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.

Enrollment: 17 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

patients with carotid plaque

Experimental group

Description:

Patients over 18 years of age with asymptomatic or symptomatic carotid plaque with a degree of stenosis \> 50% North American Symptomatic Carotid Endarterectomy Trial (NASCET) from vascular surgery consultations and for whom a surgical indication has been retained

Treatment:

Device: High resolution MRI plaque exam

Device: ultrasound imaging exam

Biological: blood sampling