Stenoses, CarotidCAROTHYDNCT05349526
Anatomical Relationship Between Carotid Artery and Hyoid Bone in Stenotic and Non-stenotic Carotids
An observational study of Stenoses, Carotid and Stroke, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Ischaemic stroke is attributable to thromboembolism caused by carotid atherosclerotic disease in 18-25% of patients. Guidelines for prevention of stroke (especially carotid endarterectomy) in patients with carotid atherosclerotic plaque are based on the quantification of the degree of stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stenoses, Carotid, Stroke
- What is being tested?
- None, pure observational study
- How many people
- 206 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2022to 15 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective analysis of preoperative CTA of 206 consecutive adult patients (>18 years of age) who underwent carotid endarterectomy for symptomatic or asymptomatic stenosis, registered in the stroke database between November 2016 and March 2020 in Nîmes University Hospital (France).
- Patients followed at the University Hospital of Nîmes between November 2016 and March 2020
- Age > 18 years
- Patients who underwent carotid endarterectomy for symptomatic or asymptomatic stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anatomical Relationship Between Carotid Artery and Hyoid Bone in Stenotic and Non-stenotic Carotids: a Cohort Study of Symptomatic and Asymptomatic Carotid Endarterectomy Patients
Ischaemic stroke is attributable to thromboembolism caused by carotid atherosclerotic disease in 18-25% of patients. Guidelines for prevention of stroke (especially carotid endarterectomy) in patients with carotid atherosclerotic plaque are based on the quantification of the degree of stenosis.
The hyoid bone, in proximity to the carotid artery, has been implicated in the pathophysiology of carotid artery dissection, atherosclerotic carotid disease, and compressive syndromes. In atherosclerotic carotid disease, pressure on the carotid artery induced by these bone structures has been proposed to play a possible role in plaque formation and rupture, leading to stenosis, occlusion, or artery-to-artery embolism. In a recent ultrasound study, dynamic displacement of the carotid artery with interference of the hyoid bone during swallowing, named as "flip-flop" phenomenon (FFP) has been associated with carotid artery stenosis and stenosis-related stroke. Another study based on CTA assessment observed no association between hyoid-carotid distance and plaque thickness, stenosis, or progression of thickness/stenosis. In that study, in almost two-third of the patients CTA was performed for stroke/transient ischemic attack work-up, including a vast majority of patients with absence of carotid stenosis (median degree of carotid stenosis was 7%), and plaque-related stroke was not assessed.
The objective of this study is to determine the anatomic hyoid-carotid interaction (ie, hyoid-carotid distance, carotid position relative to the hyoid bone, and hyoid morphology) based on CTA and its relation to the degree of carotid stenosis and stenosis-related stroke.
- Conditions
- Stenoses, Carotid, Stroke
- Being tested
- None, pure observational study
- Keywords
- computed tomography, carotid, atherosclerotic, plaque, density, stroke
- Medical subject headings
- Carotid Stenosis, Stroke, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, pure observational studyOther
None, pure observational study
| Study group | Role | What they receive |
|---|---|---|
| stenotic carotid | patients with a stenotic carotid Receives: Other: None, pure observational study | |
| non stenotic carotid | patients with non stenotic carotid Receives: Other: None, pure observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance hyoid-carotid artery
the closest distance between the hyoid bone and the outer vessel wall of the carotid artery(mm)
Measured: Base line, Day 0
Carotid artery portion closest to the hyoid bone
Depending on the level of the carotid bifurcation: common carotid artery [CCA], carotid bifurcation [CB], or internal carotid artery [ICA])
Measured: Base line, Day 0
Carotid artery position in regard to ipsilateral greater horn of the hyoid
The position of the carotid artery in regard to the ipsilateral greater horn of the hyoid (expressed in angle degree, with 0 to 90° corresponding to the posterolateral carotid position, 90 to 180° to anterolateral, 0 to -90° to posteromedial position, and -90 to-180° to anteromedial carotid position)
Measured: Base line, Day 0
Hyoid bone morphology
Hyoid width (HW), hyoid length (HL), and hyoid circumferential length (HCL)
Measured: base line, day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start15 Feb 2022
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stenoses, CarotidStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349526
- Sponsor's protocol ID
- Local/2022/DR-01
- Acronym
- CAROTHYD
- Status last verified
- May 2023
- First submitted
- 21 Apr 2022
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salaun-Penquer E, Laurent-Chabalier S, Trandafir C, Cosma C, Parvu T, Wacongne A, Thouvenot E, Renard D. Relationship between hyoid-carotid distance, hyoid position and morphology and degree of stenosis and associated stroke: Hyoid-carotid relationship. J Stroke Cerebrovasc Dis. 2025 Jan;34(1):108106. doi: 10.1016/j.jstrokecerebrovasdis.2024.108106. Epub 2024 Nov 19.
PubMed 39571666
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Relationship Between Carotid Artery and Hyoid Bone in Stenotic and Non-stenotic Carotids: a Cohort Study of Symptomatic and Asymptomatic Carotid Endarterectomy Patients
- ClinicalTrials.gov ID
- NCT05349526
- Acronym / sponsor ID
- CAROTHYD / Local/2022/DR-01
- Conditions
- Stenoses, Carotid, Stroke
- Keywords
- computed tomography, carotid, atherosclerotic, plaque, density, stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ischaemic stroke is attributable to thromboembolism caused by carotid atherosclerotic disease in 18-25% of patients. Guidelines for prevention of stroke (especially carotid endarterectomy) in patients with carotid atherosclerotic plaque are based on the quantification of the degree of stenosis.
The hyoid bone, in proximity to the carotid artery, has been implicated in the pathophysiology of carotid artery dissection, atherosclerotic carotid disease, and compressive syndromes. In atherosclerotic carotid disease, pressure on the carotid artery induced by these bone structures has been proposed to play a possible role in plaque formation and rupture, leading to stenosis, occlusion, or artery-to-artery embolism. In a recent ultrasound study, dynamic displacement of the carotid artery with interference of the hyoid bone during swallowing, named as "flip-flop" phenomenon (FFP) has been associated with carotid artery stenosis and stenosis-related stroke. Another study based on CTA assessment observed no association between hyoid-carotid distance and plaque thickness, stenosis, or progression of thickness/stenosis. In that study, in almost two-third of the patients CTA was performed for stroke/transient ischemic attack work-up, including a vast majority of patients with absence of carotid stenosis (median degree of carotid stenosis was 7%), and plaque-related stroke was not assessed.
The objective of this study is to determine the anatomic hyoid-carotid interaction (ie, hyoid-carotid distance, carotid position relative to the hyoid bone, and hyoid morphology) based on CTA and its relation to the degree of carotid stenosis and stenosis-related stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stenotic carotid | – | Other: None, pure observational studypatients with a stenotic carotid |
| non stenotic carotid | – | Other: None, pure observational studypatients with non stenotic carotid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective analysis of preoperative CTA of 206 consecutive adult patients (>18 years of age) who underwent carotid endarterectomy for symptomatic or asymptomatic stenosis, registered in the stroke database between November 2016 and March 2020 in Nîmes University Hospital (France).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None, pure observational studyNone, pure observational study | Other | non stenotic carotid, stenotic carotid |
Primary outcome
Distance hyoid-carotid artery
Time frame: Base line, Day 0
the closest distance between the hyoid bone and the outer vessel wall of the carotid artery(mm)
Carotid artery portion closest to the hyoid bone
Time frame: Base line, Day 0
Depending on the level of the carotid bifurcation: common carotid artery [CCA], carotid bifurcation [CB], or internal carotid artery [ICA])
Carotid artery position in regard to ipsilateral greater horn of the hyoid
Time frame: Base line, Day 0
The position of the carotid artery in regard to the ipsilateral greater horn of the hyoid (expressed in angle degree, with 0 to 90° corresponding to the posterolateral carotid position, 90 to 180° to anterolateral, 0 to -90° to posteromedial position, and -90 to-180° to anteromedial carotid position)
Hyoid bone morphology
Time frame: base line, day 0
Hyoid width (HW), hyoid length (HL), and hyoid circumferential length (HCL)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Results publication: PubMed 39571666Salaun-Penquer E, Laurent-Chabalier S, Trandafir C, Cosma C, Parvu T, Wacongne A, Thouvenot E, Renard D. Relationship between hyoid-carotid distance, hyoid position and morphology and degree of stenosis and associated stroke: Hyoid-carotid relationship. J Stroke Cerebrovasc Dis. 2025 Jan;34(1):108106. doi: 10.1016/j.jstrokecerebrovasdis.2024.108106. Epub 2024 Nov 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stenoses, Carotid and Stroke, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance hyoid-carotid artery (time frame: Base line, Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05349526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.