Ultrasonographic Morphology Assessment of Low-grade Carotid Stenosis (QUAMUS)
Primary Purpose
Carotid Stenosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Independent morphological quantifications by echo-doppler using ECST method
Sponsored by
About this trial
This is an interventional diagnostic trial for Carotid Stenosis focused on measuring Low-grade carotid stenosis, Ultrasound imaging, Morphological quantification, European Carotid Surgical Trial (ECST), North American Symptomatic Carotid Endarterectomy Trial (NASCET)
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
Sites / Locations
- Hôpital Sainte Musse
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Morphological quantification of low-grade carotid stenosis
Arm Description
Morphological quantification using ECST method and implying two independent observers
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To assess the performance of morphological quantification technique according to examination feasibility (good, medium, poor).
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
Full Information
NCT ID
NCT05437991
First Posted
June 24, 2022
Last Updated
October 23, 2023
Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
1. Study Identification
Unique Protocol Identification Number
NCT05437991
Brief Title
Ultrasonographic Morphology Assessment of Low-grade Carotid Stenosis
Acronym
QUAMUS
Official Title
Ultrasonographic Morphology Assessment of Low-grade Carotid Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 29, 2022 (Actual)
Primary Completion Date
January 12, 2023 (Actual)
Study Completion Date
January 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis
Keywords
Low-grade carotid stenosis, Ultrasound imaging, Morphological quantification, European Carotid Surgical Trial (ECST), North American Symptomatic Carotid Endarterectomy Trial (NASCET)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Morphological quantification of low-grade carotid stenosis
Arm Type
Other
Arm Description
Morphological quantification using ECST method and implying two independent observers
Intervention Type
Diagnostic Test
Intervention Name(s)
Independent morphological quantifications by echo-doppler using ECST method
Intervention Description
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 Measure Information:
Title
To evaluate the inter-observer reproducibility of morphological quantification of low-grade carotid stenosis (<50%) using the ECST method
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
To assess the performance of morphological quantification technique according to examination feasibility (good, medium, poor).
Description
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
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric GIAUFFRET, MD
Organizational Affiliation
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Sainte Musse
City
Toulon
State/Province
Var
ZIP/Postal Code
83100
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Ultrasonographic Morphology Assessment of Low-grade Carotid Stenosis
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