NCT05349526

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

December 4, 2025

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

April 21, 2022

Last Update Submit

November 26, 2025

Conditions

Keywords

computed tomographycarotidatheroscleroticplaquedensitystroke

Outcome Measures

Primary Outcomes (4)

  • Distance hyoid-carotid artery

    the closest distance between the hyoid bone and the outer vessel wall of the carotid artery(mm)

    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 \[ICA\])

    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)

    Base line, Day 0

  • Hyoid bone morphology

    Hyoid width (HW), hyoid length (HL), and hyoid circumferential length (HCL)

    base line, day 0

Study Arms (2)

stenotic carotid

patients with a stenotic carotid

Other: None, pure observational study

non stenotic carotid

patients with non stenotic carotid

Other: None, pure observational study

Interventions

None, pure observational study

non stenotic carotidstenotic carotid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes

Nîmes, 30029, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Carotid StenosisStrokePlaque, Amyloid

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Anissa MEGZARI

    Centre Hospitalier Universitaire de Nīmes

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

April 27, 2022

Study Start

February 15, 2022

Primary Completion

August 15, 2022

Study Completion

August 15, 2022

Last Updated

December 4, 2025

Record last verified: 2023-05

Locations