Carotid Plaque Characterization Using Innovative Ultrasound Techniques

NCT ID: NCT06804707

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-10
• Study Completion Date: 2027-01-10

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.

Conditions

Carotid Atheroma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

patients with carotid plaque

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

Group Type: EXPERIMENTAL

blood sampling

Intervention Type: BIOLOGICAL

This procedure will take place once during the patient's CARPUS first visit (Croix Rousse hospital (Hospice civils de Lyon).

A peripheral venous line of the cathlon 24 G type with tap without tubing will be inserted by a nurse. A blood sample will be taken at the same time to check creatinine levels before the MRI scan and to record the patient's cholesterol levels for the eCRF.

ultrasound imaging exam

Intervention Type: DEVICE

This procedure takes place once immediately after the intervention 1. The patient will first have an ultrasound acquisition with the clinical ultrasound scanner (~5 minutes) in order to locate the plaque. An acquisition with the research ultrasound scanner and matrix probe will then be performed for measurement for ultrasound spectroscopy (~5 minutes).

An injection of 2.4 ml Sonovue followed by 10 ml saline will be performed during acquisition with the research ultrasound scanner for ultrasound localization imaging measurement (~10 minutes).

The patient must remain under observation (in the waiting room) for 30 minutes after the examination.

High resolution MRI plaque exam

Intervention Type: DEVICE

This procedure will take place once during the patient's CARPUS second visit (Pierre Wertheimer hospital (Hospice civils de Lyon)).

The patient is greeted in radiology, and his/her identity and absence of contraindications are verified.

A peripheral venous line of the cathlon 24 G type with tap without tubing will be inserted by a nurse.

Injection of gadolinium and MRI examination of the plaque used in clinical routine.

Interventions

blood sampling

This procedure will take place once during the patient's CARPUS first visit (Croix Rousse hospital (Hospice civils de Lyon).

A peripheral venous line of the cathlon 24 G type with tap without tubing will be inserted by a nurse. A blood sample will be taken at the same time to check creatinine levels before the MRI scan and to record the patient's cholesterol levels for the eCRF.

Intervention Type: BIOLOGICAL

ultrasound imaging exam

This procedure takes place once immediately after the intervention 1. The patient will first have an ultrasound acquisition with the clinical ultrasound scanner (~5 minutes) in order to locate the plaque. An acquisition with the research ultrasound scanner and matrix probe will then be performed for measurement for ultrasound spectroscopy (~5 minutes).

An injection of 2.4 ml Sonovue followed by 10 ml saline will be performed during acquisition with the research ultrasound scanner for ultrasound localization imaging measurement (~10 minutes).

The patient must remain under observation (in the waiting room) for 30 minutes after the examination.

Intervention Type: DEVICE

High resolution MRI plaque exam

This procedure will take place once during the patient's CARPUS second visit (Pierre Wertheimer hospital (Hospice civils de Lyon)).

The patient is greeted in radiology, and his/her identity and absence of contraindications are verified.

A peripheral venous line of the cathlon 24 G type with tap without tubing will be inserted by a nurse.

Injection of gadolinium and MRI examination of the plaque used in clinical routine.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Ariane BLEROT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hôpital de la Croix Rousse

Lyon, , France

Countries

France

Central Contacts

Dr. Ariane BLEROT, MD, PhD

Role: CONTACT

ariane.blerot@chu-lyon.fr

+33 4.72.07.16.78

Pauline MULEKI-SEYA, PhD

Role: CONTACT

pauline.muleki-seya@creatis.insa-lyon.fr

+33 4.72.43.83.32

Facility Contacts

Dr. Ariane BLEROT, MD, PhD

Role: primary

ariane.blerot@chu-lyon.fr

+33.04.72.07.16.78

Other Identifiers

69HCL24_0689

Identifier Type: -

Identifier Source: org_study_id