Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06398223

Ocular Perfusion in Patients With Unilateral Carotid Artery Stenosis

Status
Recruiting
Phase
Study type
Observational
Enrollment
45 (estimated)
Sponsor
Medical University of Vienna · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

Summary

The aim of the presented study is to evaluate ocular blood flow, respectively optic nerve head blood flow in patients with carotid artery stenosis before and after carotid endarterectomy or carotid artery stenting. Additionally, the investigators aim to compare optic nerve head blood flow in patients with CAS and healthy age- and sex-matched control subjects. Furthermore, the investigators intend to evaluate brain tissue oxygenation in patients with carotid artery stenosis before, during and after CEA and carotid artery stenting. Finally, the investigators will assess potential correlations between LSFG and NIRS results in patients with unilateral carotid artery stenosis.

Detailed description

Carotid artery stenosis is a condition that can lead to severe consequences such as ocular ischemia or stroke. As the ophthalmic artery branches off the carotid artery, ocular ischemic complications include amaurosis fugax, ocular ischemic syndrome or central retinal artery occlusion. Hence, early diagnosis of carotid artery stenosis and ocular perfusion impairment is of considerable importance to prevent ocular and systemic ischemic complications. As the retina offers a unique window for examining the microcirculation in a non-invasive manner, several imaging techniques have already been used in recent years to assess ocular alterations associated with carotid artery stenosis. However, these examination techniques have their limitations and are therefore not suitable methods for determining ocular perfusion. On the contrary, Laser Speckle Flowgraphy (LSFG) is a non-invasive, in-vivo imaging method which quantitatively estimates blood flow in the optic nerve head, the choroid, the retina and the iris. LSFG offers a promising alternative from conventional methods, as it eliminates the need for contrast agents, has a low procedural complexity and obtains precise and reproducible measurements. As the eye and brain share a close vascular relationship, both receiving blood supply from branches of the internal carotid artery, there is potential to establish a correlation between cerebral and ocular hemodynamics. Near-infrared spectroscopy (NIRS) is a simple and non-invasive method which enables continuous assessment of cerebral oxygenation. However, data on the course of oxygenation of the brain tissue using NIRS before, during and after carotid interventions are scarce. Additionally, there is a lack of comparative NIRS data between carotid endarterectomy (CEA) and carotid artery stenting. Furthermore, correlation studies between oxygenation of the brain tissue and ocular perfusion are largely missing. Hence, the aim of this study is to evaluate optic nerve head blood flow in patients with carotid artery stenosis before and after CEA or carotid artery stenting. Additionally, the investigators will compare optic nerve head blood flow in patients with carotid artery stenosis to healthy sex- and age-matched control subjects. Furthermore, the investigators intend to evaluate brain tissue oxygenation in patients with carotid artery stenosis before, during and after CEA and carotid artery stenting. Finally, the investigators will assess potential correlations between LSFG and NIRS results in patients with unilateral carotid artery stenosis.

Conditions

Interventions

TypeNameDescription
PROCEDURECarotid endarterectomy (CEA)Carotid endarterectomy (CEA): Surgical procedure to remove the plaque buildup in the carotid artery.
PROCEDURECarotid artery stentingCarotid artery stenting: Treatment of the stenosis with a stent. The plaque in the artery wall is not removed but the narrowing is dilated.

Timeline

Start date
2024-04-09
Primary completion
2026-05-02
Completion
2026-05-02
First posted
2024-05-03
Last updated
2024-05-03

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT06398223. Inclusion in this directory is not an endorsement.