Ocular Perfusion in Patients With Unilateral Carotid Artery Stenosis
NCT ID: NCT06398223
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
45 participants
OBSERVATIONAL
2024-04-09
2026-05-02
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Carotid endarterectomy (CEA) (Group 1)
Subjects with unilateral carotid artery stenosis and planned CEA
Carotid endarterectomy (CEA)
Carotid endarterectomy (CEA): Surgical procedure to remove the plaque buildup in the carotid artery.
Carotid artery stenting (Group 2)
Subjects with unilateral carotid artery stenosis and planned carotid artery stenting
Carotid artery stenting
Carotid artery stenting: Treatment of the stenosis with a stent. The plaque in the artery wall is not removed but the narrowing is dilated.
Healthy Control Group (Group 3)
Healthy age- and sex-matched control subjects
No interventions assigned to this group
Interventions
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Carotid endarterectomy (CEA)
Carotid endarterectomy (CEA): Surgical procedure to remove the plaque buildup in the carotid artery.
Carotid artery stenting
Carotid artery stenting: Treatment of the stenosis with a stent. The plaque in the artery wall is not removed but the narrowing is dilated.
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
* Normal ophthalmic findings, unless the investigator considers an abnormality to be clinically irrelevant
* Diagnosis of unilateral carotid artery stenosis and scheduled carotid endarterectomy or carotid artery stenting
* Men and Women aged ≥ 18 years
* Signed informed consent
* Normal ophthalmic findings, unless the investigator considers an abnormality to be clinically irrelevant
* Normal findings in the medical history, unless the investigator considers an abnormality to be clinically irrelevant
* Non-Smokers
Exclusion Criteria
* Symptoms of a clinically relevant illness in the three weeks preceding the study
* Ocular inflammation or infection within the last 3 months
* History of family history of epilepsy
* Diabetes mellitus type 1 or type 2
* Pregnant or breast-feeding women
* Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception
18 Years
ALL
No
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Gerhard Garhofer
Assoc. Prof. Priv. Doz. Dr. med. univ.
Locations
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Department of Clincal Pharmacology, Medical University of Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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References
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Ismail A, Ravipati S, Gonzalez-Hernandez D, Mahmood H, Imran A, Munoz EJ, Naeem S, Abdin ZU, Siddiqui HF. Carotid Artery Stenosis: A Look Into the Diagnostic and Management Strategies, and Related Complications. Cureus. 2023 May 9;15(5):e38794. doi: 10.7759/cureus.38794. eCollection 2023 May.
Lahme L, Marchiori E, Panuccio G, Nelis P, Schubert F, Mihailovic N, Torsello G, Eter N, Alnawaiseh M. Changes in retinal flow density measured by optical coherence tomography angiography in patients with carotid artery stenosis after carotid endarterectomy. Sci Rep. 2018 Nov 21;8(1):17161. doi: 10.1038/s41598-018-35556-4.
Pierro L, Arrigo A, De Crescenzo M, Aragona E, Chiesa R, Castellano R, Catenaccio B, Bandello F. Quantitative Optical Coherence Tomography Angiography Detects Retinal Perfusion Changes in Carotid Artery Stenosis. Front Neurosci. 2021 Apr 22;15:640666. doi: 10.3389/fnins.2021.640666. eCollection 2021.
Woo SY, Joh JH, Han SA, Park HC. Prevalence and risk factors for atherosclerotic carotid stenosis and plaque: A population-based screening study. Medicine (Baltimore). 2017 Jan;96(4):e5999. doi: 10.1097/MD.0000000000005999.
Hackam DG. Optimal Medical Management of Asymptomatic Carotid Stenosis. Stroke. 2021 Jun;52(6):2191-2198. doi: 10.1161/STROKEAHA.120.033994. Epub 2021 May 5.
Kwapong WR, Liu J, Wan J, Tao W, Ye C, Wu B. Retinal Thickness Correlates with Cerebral Hemodynamic Changes in Patients with Carotid Artery Stenosis. Brain Sci. 2022 Jul 25;12(8):979. doi: 10.3390/brainsci12080979.
Song P, Fang Z, Wang H, Cai Y, Rahimi K, Zhu Y, Fowkes FGR, Fowkes FJI, Rudan I. Global and regional prevalence, burden, and risk factors for carotid atherosclerosis: a systematic review, meta-analysis, and modelling study. Lancet Glob Health. 2020 May;8(5):e721-e729. doi: 10.1016/S2214-109X(20)30117-0.
Cohen R, Padilla J, Light D, Diller R. Carotid artery occlusive disease and ocular manifestations: Importance of identifying patients at risk. Optometry. 2010 Jul;81(7):359-63. doi: 10.1016/j.optm.2009.10.013.
Batu Oto B, Kilicarslan O, Kayadibi Y, Yilmaz Cebi A, Adaletli I, Yildirim SR. Retinal Microvascular Changes in Internal Carotid Artery Stenosis. J Clin Med. 2023 Sep 16;12(18):6014. doi: 10.3390/jcm12186014.
Arthur A, Alexander A, Bal S, Sivadasan A, Aaron S. Ophthalmic masquerades of the atherosclerotic carotids. Indian J Ophthalmol. 2014 Apr;62(4):472-6. doi: 10.4103/0301-4738.121183.
Mursch-Edlmayr AS, Luft N, Podkowinski D, Ring M, Schmetterer L, Bolz M. Laser speckle flowgraphy derived characteristics of optic nerve head perfusion in normal tension glaucoma and healthy individuals: a Pilot study. Sci Rep. 2018 Mar 28;8(1):5343. doi: 10.1038/s41598-018-23149-0.
Luft N, Wozniak PA, Aschinger GC, Fondi K, Bata AM, Werkmeister RM, Schmidl D, Witkowska KJ, Bolz M, Garhofer G, Schmetterer L. Ocular Blood Flow Measurements in Healthy White Subjects Using Laser Speckle Flowgraphy. PLoS One. 2016 Dec 13;11(12):e0168190. doi: 10.1371/journal.pone.0168190. eCollection 2016.
Bissacco D, Attisani L, Settembrini AM, Fossati A, Carmo M, Dallatana R, Settembrini PG. Modifications in Near Infrared Spectroscopy for Cerebral Monitoring During Carotid Endarterectomy in Asymptomatic and Symptomatic Patients. Ann Vasc Surg. 2022 Feb;79:239-246. doi: 10.1016/j.avsg.2021.06.047. Epub 2021 Oct 10.
Ismail A, Chen HC, Faye I, Tang TB. Longitudinal effects of common carotid artery stenosis on ocular hemodynamics assessed using laser speckle flowgraphy in a rabbit model. Sci Rep. 2020 Sep 28;10(1):15829. doi: 10.1038/s41598-020-72556-9.
Other Identifiers
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OPHT-101023
Identifier Type: -
Identifier Source: org_study_id
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