Carotid AtheromaCARPUSNCT06804707
Carotid Plaque Characterization Using Innovative Ultrasound Techniques
A study testing blood sampling, ultrasound imaging exam and High resolution MRI plaque exam in people with Carotid Atheroma, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Atheroma
- What is being tested?
- blood sampling, ultrasound imaging exam and High resolution MRI plaque exam
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2025to 13 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital de la Croix Rousse
Lyon, 69004
Dr. Ariane BLEROT, MD, PhD, +33.04.72.07.16.78, ariane.blerot@chu-lyon.fr
Dr Ariane BLEROT, MD, PhD
About this study
Official title: Tissue and Vascular Microstructure Evaluation for Carotid Plaque Characterization Using Innovative Ultrasound Techniques
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
- Being tested
- blood sampling, ultrasound imaging exam, High resolution MRI plaque exam
- Keywords
- Carotid atheroma, Plaque characterization, Ultrasound, Ultrasound Localization Microscopy, Backscatter Coefficient, Vasa vasorum, Intraplaque Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
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 examDevice
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 examDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| patients with carotid plaque | Experimental | 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 Receives: Biological: blood sampling; Device: ultrasound imaging exam; Device: High resolution MRI plaque exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of neovessels in carotid atherosclerotic plaques by ULM
From the vascularization cartography obtained by ULM, the volume of vascularization of the plaque will be estimated (number of pixels with vascularization compared with the number of pixels in the plaque x100). Plaques can then be described by neovessel volume distribution.
Measured: between 6 and 59 days after inclusion
Mean velocity in neovessels in carotid atherosclerotic plaques by ULM
From the vascularization cartography obtained by ULM, the mean velocity (mm/s) in all the neovessels will be estimated.
Measured: between 6 and 59 days after inclusion
Location of neovessels in carotid atherosclerotic plaques by ULM
The main location of vessels will also be described according to their topography in the plaque (e.g. central, peripheral, both).
Measured: between 6 and 59 days after inclusion
Secondary outcomes (7)
Lizzi Feleppa slope (dB/MHz) derived from BSC measured by ultrasound spectroscopy on carotid atherosclerotic plaques
In ultrasound signals, the plaque is divided into regions of interest and ultrasound spectroscopy is applied. This will enable us to obtain the backscatter coefficient (BSC) for each region of interest. From the backscatter coefficient, parameters derived from the BSC will be evaluated.
One of these parameters is:
- Lizzi-Feleppa slope: slope of the linear fit of the BSC as a function of frequency.
This parameter in the different regions of interest on the plaque will be averaged for each plaque.
Measured: between 6 and 59 days after inclusion
Lizzi Feleppa intercept (dB) derived from BSC measured by ultrasound spectroscopy on carotid atherosclerotic plaques
In ultrasound signals, the plaque is divided into regions of interest and ultrasound spectroscopy is applied. This will enable us to obtain the backscatter coefficient (BSC) for each region of interest. From the backscatter coefficient, parameters derived from the BSC will be evaluated.
One of these parameters is:
- Lizzi-Feleppa intercept: intercept of the linear fit of the BSC as a function of frequency.
This parameter in the different regions of interest on the plaque will be averaged for each plaque.
Measured: between 6 and 59 days after inclusion
Lizzi Feleppa midband (dB) derived from BSC measured by ultrasound spectroscopy on carotid atherosclerotic plaques
In ultrasound signals, the plaque is divided into regions of interest and ultrasound spectroscopy is applied. This will enable us to obtain the backscatter coefficient (BSC) for each region of interest. From the backscatter coefficient, parameters derived from the BSC will be evaluated.
One of these parameters is:
- Lizzi-Feleppa midband: midband of the linear fit of the BSC as a function of frequency.
This parameter in the different regions of interest on the plaque will be averaged for each plaque.
Measured: between 6 and 59 days after inclusion
Integrated backscatter coefficient (BSC) (dB) measured by ultrasound spectroscopy on carotid atherosclerotic plaques
In ultrasound signals, the plaque is divided into regions of interest and ultrasound spectroscopy is applied. This will enable us to obtain the backscatter coefficient (BSC) for each region of interest. From the backscatter coefficient, parameters derived from the BSC will be evaluated.
One of these parameters is:
- integrated BSC: Integrated BSC on the -6 dB frequency bandwidth.
This parameter in the different regions of interest on the plaque will be averaged for each plaque.
Measured: between 6 and 59 days after inclusion
Acoustic attenuation (dB/mm) measured by ultrasound on carotid atherosclerotic plaques
In ultrasound signals, the plaque is divided into regions of interest and ultrasound spectroscopy is applied. This will enable us to obtain the backscatter coefficient (BSC) for each region of interest. From the backscatter coefficient, parameters derived from the BSC will be evaluated.
One of these parameters is:
- acoustic attenuation.
This parameter in the different regions of interest on the plaque will be averaged for each plaque.
Measured: between 6 and 59 days after inclusion
Correlation between the volume of neovessels in carotid atherosclerotic plaques, estimated by ULM, and that estimated by anatomopathological analyses
For each plaque, histological analysis will give the stage of intraplaque haemorrhage according to Derksen's grading scale if intraplaque haemorrhage is present. A semi-quantitative grading denoting the quantity of neovessels (score between 0 and 3) will also be performed. The correlation between these grades and the volume of neovessels originating from the ULM will be studied.
Measured: between 6 and 59 days after inclusion
Correlation between ultrasound parameters of BSC related to intraplaque hemorrhage of carotid atherosclerotic plaques and intraplaque hemorrhage assessed by anatomopathological analyses
Histological analysis will give the stage of intraplaque haemorrhage according to Derksen's grading scale if intraplaque haemorrhage is present. A semi-quantitative scale denoting the ratio of the area of intraplaque hemorrhage to the total area of the plaque (score 0 if ratio between 0 and 25%, score 1 if ratio between 25 and 50%, score 2 if ratio between 50 and 75% and score 3 if ratio between 75 and 100%). The thresholds for the BSC parameters need to be calibrated to determine the thresholds corresponding to intraplaque hemorrhage. For this step, areas of intraplaque hemorrhage will be localized using plaque MRI. This will enable us to determine which BSC parameter or combination of parameters best characterizes intraplaque hemorrhage, and then to estimate for each plaque a relative volume of region of interest containing intraplaque hemorrhage.
The correlation between these grades and the volume of intraplaque hemorrhage derived from ultrasound measurements will be studied.
Measured: between 6 and 59 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start13 May 2025
- Primary completion13 Feb 2027 (estimated)
- Study completion13 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid AtheromaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-center, cross-sectional, descriptive and exploratory study.
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Ariane BLEROT, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804707
- Sponsor's protocol ID
- 69HCL24_0689
- Acronym
- CARPUS
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue and Vascular Microstructure Evaluation for Carotid Plaque Characterization Using Innovative Ultrasound Techniques
- ClinicalTrials.gov ID
- NCT06804707
- Acronym / sponsor ID
- CARPUS / 69HCL24_0689
- Conditions
- Carotid Atheroma
- Keywords
- Carotid atheroma, Plaque characterization, Ultrasound, Ultrasound Localization Microscopy, Backscatter Coefficient, Vasa vasorum, Intraplaque Hemorrhage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 13 Feb 2027 (estimated)
- Study completion
- 13 Feb 2027 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-center, cross-sectional, descriptive and exploratory study.
| Arm | Type | Receives |
|---|---|---|
| patients with carotid plaque | Experimental | Biological: blood sampling, Device: ultrasound imaging exam, Device: High resolution MRI plaque examPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingThis 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. | Biological | patients with carotid plaque |
| ultrasound imaging examThis 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. | Device | patients with carotid plaque |
| High resolution MRI plaque examThis 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. | Device | patients with carotid plaque |
Primary outcome
Volume of neovessels in carotid atherosclerotic plaques by ULM
Time frame: between 6 and 59 days after inclusion
From the vascularization cartography obtained by ULM, the volume of vascularization of the plaque will be estimated (number of pixels with vascularization compared with the number of pixels in the plaque x100). Plaques can then be described by neovessel volume distribution.
Mean velocity in neovessels in carotid atherosclerotic plaques by ULM
Time frame: between 6 and 59 days after inclusion
From the vascularization cartography obtained by ULM, the mean velocity (mm/s) in all the neovessels will be estimated.
Location of neovessels in carotid atherosclerotic plaques by ULM
Time frame: between 6 and 59 days after inclusion
The main location of vessels will also be described according to their topography in the plaque (e.g. central, peripheral, both).
7 secondary outcomes
Lizzi Feleppa slope (dB/MHz) derived from BSC measured by ultrasound spectroscopy on carotid atherosclerotic plaques
Time frame: between 6 and 59 days after inclusion
Lizzi Feleppa intercept (dB) derived from BSC measured by ultrasound spectroscopy on carotid atherosclerotic plaques
Time frame: between 6 and 59 days after inclusion
Lizzi Feleppa midband (dB) derived from BSC measured by ultrasound spectroscopy on carotid atherosclerotic plaques
Time frame: between 6 and 59 days after inclusion
Integrated backscatter coefficient (BSC) (dB) measured by ultrasound spectroscopy on carotid atherosclerotic plaques
Time frame: between 6 and 59 days after inclusion
Acoustic attenuation (dB/mm) measured by ultrasound on carotid atherosclerotic plaques
Time frame: between 6 and 59 days after inclusion
Correlation between the volume of neovessels in carotid atherosclerotic plaques, estimated by ULM, and that estimated by anatomopathological analyses
Time frame: between 6 and 59 days after inclusion
Correlation between ultrasound parameters of BSC related to intraplaque hemorrhage of carotid atherosclerotic plaques and intraplaque hemorrhage assessed by anatomopathological analyses
Time frame: between 6 and 59 days after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Ariane BLEROT, MD, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling, ultrasound imaging exam and High resolution MRI plaque exam in people with Carotid Atheroma, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Ariane BLEROT, MD, PhD (+33 4.72.07.16.78, ariane.blerot@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of neovessels in carotid atherosclerotic plaques by ULM (time frame: between 6 and 59 days after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.