Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398223
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-22
Brief Title:
Ocular Perfusion in Patients With Unilateral Carotid Artery Stenosis
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Ocular Perfusion in Patients With Unilateral Carotid Artery Stenosis
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None