- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05349526
Anatomical Relationship Between Carotid Artery and Hyoid Bone in Stenotic and Non-stenotic Carotids (CAROTHYD)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Nîmes, France, 30029
- CHU de Nîmes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
stenotic carotid
patients with a stenotic carotid
|
None, pure observational study
|
|
non stenotic carotid
patients with non stenotic carotid
|
None, pure observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Base line, Day 0
|
|
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])
|
Base line, Day 0
|
|
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)
|
Base line, Day 0
|
|
Hyoid bone morphology
Time Frame: base line, day 0
|
Hyoid width (HW), hyoid length (HL), and hyoid circumferential length (HCL)
|
base line, day 0
|
Collaborators and Investigators
Investigators
- Study Director: Anissa MEGZARI, Centre Hospitalier Universitaire de Nimes
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathological Conditions, Anatomical
- Arterial Occlusive Diseases
- Carotid Artery Diseases
- Pathological Conditions, Signs and Symptoms
- Stroke
- Carotid Stenosis
- Plaque, Amyloid
Other Study ID Numbers
- Local/2022/DR-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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