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Ultrasonographic Morphology Assessment of Low-grade Carotid Stenosis (QUAMUS)

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ClinicalTrials.gov Identifier: NCT05437991
Recruitment Status : Recruiting
First Posted : June 29, 2022
Last Update Posted : October 12, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

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.


Condition or disease Intervention/treatment Phase
Carotid Stenosis Diagnostic Test: Independent morphological quantifications by echo-doppler using ECST method Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 83 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ultrasonographic Morphology Assessment of Low-grade Carotid Stenosis
Actual Study Start Date : September 29, 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Morphological quantification of low-grade carotid stenosis
Morphological quantification using ECST method and implying two independent observers
Diagnostic Test: Independent morphological quantifications by echo-doppler using ECST method
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.




Primary Outcome Measures :
  1. To evaluate the inter-observer reproducibility of morphological quantification of low-grade carotid stenosis (<50%) using the ECST method [ Time Frame: 1 day ]
    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.


Secondary Outcome Measures :
  1. To assess the performance of morphological quantification technique according to examination feasibility (good, medium, poor). [ Time Frame: 1 day ]

    The examination feasibility will be based on subjective assessment of the conditions under which the measurements are made (systolic and diastolic velocities in the internal carotid artery, diameter of the patent lumen, diameter of the vessel at the site of stenosis):

    • Good: no doubt about measurements accuracy
    • Medium: more difficult to make accurate measurements
    • Poor: significant doubt about measurements accuracy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05437991


Contacts
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Contact: Sophie LAFOND 04 83 77 20 62 ext +33 sophie.lafond@ch-toulon.fr

Locations
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France
Hôpital Sainte Musse Recruiting
Toulon, Var, France, 83100
Contact: Frédéric GIAUFFRET, MD    04 94 14 58 11 ext +33    Frederic.Giauffret@ch-toulon.fr   
Sponsors and Collaborators
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Investigators
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Study Director: Frédéric GIAUFFRET, MD Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
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Responsible Party: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier: NCT05437991    
Other Study ID Numbers: 2022-CHITS-005
2022-A00854-39 ( Other Identifier: ID-RCB )
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer:
Low-grade carotid stenosis
Ultrasound imaging
Morphological quantification
European Carotid Surgical Trial (ECST)
North American Symptomatic Carotid Endarterectomy Trial (NASCET)
Additional relevant MeSH terms:
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Carotid Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases