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CARPUS
Tissue and Vascular Microstructure Evaluation for Carotid Plaque Characterization Using Innovative Ultrasound Techniques
Sponsor study identifier
interventional
17
1 country
1
Study Start
May 13, 2025
Actual (reported)Primary Completion
February 13, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 13, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 13, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 27, 2025
Actual (reported)February 3, 2025
Actual (reported)May 13, 2025
Actual (reported)February 13, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 13, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
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).
between 6 and 59 days after inclusion
Lizzi Feleppa slope (dB/MHz) derived from BSC measured by ultrasound spectroscopy on carotid atherosclerotic plaques
between 6 and 59 days after inclusion
Lizzi Feleppa intercept (dB) derived from BSC measured by ultrasound spectroscopy on carotid atherosclerotic plaques
between 6 and 59 days after inclusion
Lizzi Feleppa midband (dB) derived from BSC measured by ultrasound spectroscopy on carotid atherosclerotic plaques
between 6 and 59 days after inclusion
Integrated backscatter coefficient (BSC) (dB) measured by ultrasound spectroscopy on carotid atherosclerotic plaques
between 6 and 59 days after inclusion
Acoustic attenuation (dB/mm) measured by ultrasound on carotid atherosclerotic plaques
between 6 and 59 days after inclusion
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
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.
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.
Hôpital de la Croix Rousse
Lyon, 69004, France
Dr Ariane BLEROT, MD, PhD
Hospices Civils de Lyon
First Submitted
January 27, 2025
First Posted
February 3, 2025
Study Start
May 13, 2025
Actual (reported)Primary Completion
February 13, 2027
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.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 13, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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