Anatomical Relationship Between Carotid Artery and Hyoid Bone in Stenotic and Non-stenotic Carotids

Stroke Clinical Trial

— CAROTHYD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05349526
• Other study ID #: Local/2022/DR-01
• Status: Completed
• Start date: February 15, 2022
• Est. completion date: August 16, 2022

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: August 16, 2022
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Carotid Stenosis
• Stroke

Intervention

Other:
• None, pure observational study
None, pure observational study

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Hyoid bone morphology	Hyoid width (HW), hyoid length (HL), and hyoid circumferential length (HCL)	base line, day 0