Ultrasonographic Morphology Assessment of Low-grade Carotid Stenosis

NCT05437991 | Completed

• 2 other identifiers: 2022-CHITS-0052022-A00854-39
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Stenosis

Keywords

Low-grade carotid stenosis; Ultrasound imaging; Morphological quantification; European Carotid Surgical Trial (ECST); North American Symptomatic Carotid Endarterectomy Trial (NASCET)

Outcome Measures

Primary Outcomes (1)

• To evaluate the inter-observer reproducibility of morphological quantification of low-grade carotid stenosis (<50%) using the ECST method

  Each operators will perform stenosis percentage calculation according to ECST method. Between the two calculations performed independently by the two observers, a difference of ±10% will be considered acceptable.

  1 day

Secondary Outcomes (1)

• To assess the performance of morphological quantification technique according to examination feasibility (good, medium, poor).

  1 day

Study Arms (1)

Morphological quantification of low-grade carotid stenosis

OTHER

Morphological quantification using ECST method and implying two independent observers

Diagnostic Test: Independent morphological quantifications by echo-doppler using ECST method

Interventions

Independent morphological quantifications by echo-doppler using ECST method DIAGNOSTIC_TEST

The physician who is usually in charge of patient follow-up performs a first evaluation of carotid stenosis percentage by echo-doppler using ECST method. Then a second physician immediately performs a second evaluation using the same echo-doppler device without knowing first evaluation conclusions.

Morphological quantification of low-grade carotid stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

Hôpital Sainte Musse

Toulon, Var, 83100, France

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Frédéric GIAUFFRET, MD

  Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: September 29, 2022
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: July 1, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)