Clinical trial NCT05437991: Ultrasonographic Morphology Assessment of Low-grade Carotid Stenosis
Official title: Ultrasonographic Morphology Assessment of Low-grade Carotid Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Stenosis
Keywords: Low-grade carotid stenosis
Ultrasound imaging
Morphological quantification
European Carotid Surgical Trial (ECST)
North American Symptomatic Carotid Endarterectomy Trial (NASCET)
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Internal carotid artery (ICA) is intended to supply blood to brain. The carotid bulb located upstream of ICA origin is prone to atherosclerosis. This is an accumulation of fat and calcium in the wall forming a plaque that gradually thickens and leads to carotid stenosis (CS), which causes a decrease in blood flow. The risk of CS is stroke caused either by carotid artery thrombosis (occlusion) or by atherosclerotic plaque fragmentation, some components of which may leak into the brain (embolism).

When diagnosing CS, an Echo-Doppler is performed to determine bulb and ICA origin obstruction rates. The reference method of quantifying CS is based on hemodynamic criteria that only allow the diagnosis of high grade stenosis thresholds (50%-70%). Below 50%, low-grade stenosis, patient follow-up is limited and could be based on morphological criteria; ultrasound imaging being a reference technique for human body structures morphological assessment, especially vessels.

Two methods of CS morphological quantification with Doppler ultrasound currently exist. Calibre reduction at the maximum of stenosis can be measured by relating the smallest luminal diameter to the vessel diameter at stenosis site (ECST method) or to the downstream ICA diameter (NASCET method). As bulb diameter measures ≈1.8 times that of ICA, ECST appears to be more suitable for CS quantification. For high-grade stenosis, morphological quantification performance is impaired due to extensive calcification of large atheromatous plaques. However, it is possible that less calcified nature of low-grade stenosis and the use of a rigorous methodology will allow reproducible assessment in routine practice. This technique has not yet been evaluated, although it is a frequent situation in patient follow-up.

Detailed description: Internal carotid artery is intended to supply blood to brain. The carotid bulb located upstream of internal carotid artery origin is prone to atherosclerosis. This is an accumulation of fat and calcium in the wall, forming a plaque which gradually thickens and leads to carotid stenosis, causing a reduction in blood flow. The risk of carotid stenosis is stroke caused either by carotid artery thrombosis (occlusion) or by atherosclerotic plaque fragmentation, some components of which may leak into the brain (embolism).

When carotid stenosis is diagnosed, an Echo-Doppler is performed to determine the bulb and internal carotid artery origin obstruction rates. The reference method for quantifying carotid stenosis is based on hemodynamic criteria that only allow the diagnosis of high grade stenosis thresholds (50%-70%). Below 50%, low-grade stenosis, patient follow-up is limited and could be based on morphological criteria; ultrasound imaging being a reference technique for human body structures morphological assessment, especially vessels.

Two methods of carotid stenosis morphological quantification with Doppler ultrasound currently exist. Calibre reduction at the maximum of stenosis can be measured by relating the smallest luminal diameter to the vessel diameter at stenosis site ("European Carotid Surgical Trial" (ECST), European method) or to the downstream internal carotid artery diameter ("North American Symptomatic Carotid Endarterectomy Trial" (NASCET), North American method). As bulb diameter measures ≈1.8 times that of the internal carotid artery, the NASCET appears to be more suitable for carotid stenosis quantification. For high-grade stenosis, morphological quantification performance is impaired due to extensive calcification of large atheromatous plaques. However, it is possible that less calcified nature of low-grade stenosis and the use of a rigorous methodology will allow reproducible assessment in routine practice.

This technique has not yet been evaluated although it is a frequent situation in patient follow-up. This study therefore suggests to evaluate the inter-observer reproducibility of morphological quantification of these stenosis by the ECST method with a precise methodology.

Eligibility criteria: Inclusion Criteria:

* Outpatient referred for Echo-Doppler exploration of the neck vessels
* Patient 18 years of age or older
* Atheromatous arterial disease with stenosis \< 50% (maximum systolic velocity \< 125 cm/sec for an angle of 50-60°) in at least one carotid artery

Exclusion Criteria:

* Patient refusal
* Unavailability of two physicians to perform examination
* Patient under judicial protection (guardianship, curators...) or justice safeguard
* Pregnant, parturient or breastfeeding woman
* Any other reason that could interfere with study objectives evaluation in the investigator opinion

Primary outcomes:
measure: To evaluate the inter-observer reproducibility of morphological quantification of low-grade carotid stenosis (<50%) using the ECST method
timeFrame: 1 day
Secondary outcomes:
measure: To assess the performance of morphological quantification technique according to examination feasibility (good, medium, poor).
timeFrame: 1 day
Other outcomes:
Locations:
city: Toulon
country: France
facility: Hôpital Sainte Musse
state: Var
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Frédéric GIAUFFRET, MD
role: STUDY_DIRECTOR
References:
citation: Giauffret F, Hocq F, Lafond S, Autret A, Elias A, European Carotid Surgical Trial-based diameter measurement using B-mode ultrasound imaging to quantify low-grade carotid artery stenosis: the QUAMUS study. JVS-Vascular Insights. Volume 2, 2024, 100061