Study protocol - Prospective case-control trial - Impact of significant carotid stenosis on retinal perfusion measured with automated retinal oximetry
Language English Country Czech Republic Media print-electronic
Document type Journal Article, Clinical Trial Protocol
PubMed
38192247
DOI
10.5507/bp.2023.052
Knihovny.cz E-resources
- Keywords
- arterio-venous difference, automated retinal oximetry, carotid stenosis, ischaemic stroke, magnetic resonance imaging,
- MeSH
- Humans MeSH
- Oximetry * methods MeSH
- Prospective Studies MeSH
- Retina * physiopathology MeSH
- Retinal Vessels * physiopathology MeSH
- Aged MeSH
- Carotid Stenosis * physiopathology diagnostic imaging complications MeSH
- Case-Control Studies MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial Protocol MeSH
BACKGROUND: Large vessel carotid stenosis is a significant cause of ischaemic stroke. Indications for surgical revascularisation depend on the severity of the stenosis and clinical symptoms. However, mild symptoms such as TIA (Transient ischaemic attack), amaurosis fugax or minor stroke precede large strokes in only 15% of cases. AIM: The aim of this prospective study is to evaluate whether retinal perfusion is impacted in significant carotid stenosis. Automated retinal oximetry will be used to better assess perfusion in the post-stenotic basin. We presume the more stenotic the blood vessel, the more reduced the retinal perfusion is, resulting in adaptive changes such as greater arteriovenous saturation difference due to greater oxygen extraction. This could broaden the indication spectrum for revascularisation for carotid stenosis. METHODS: We plan to enroll yearly 50 patients with significant carotid stenosis and cross-examine them with retinal oximetry. The study group will provide stenotic vessels and, non-stenotic vessels will form the control group. Patients with significant carotid stenosis will undergo an MRI (Magnetic Resonnance imaging) examination to determine the presence of asymptomatic recent ischaemic lesions in the stenotic basin, and the correlation to oximetry parameters. STATISTICS: The stenosis severity and retinal oximetry parameters will be compared for study and control groups with a threshold of 70%, respectively 80% and 90% stenosis. Results will be then reevaluated with emphasis on MRI findings in the carotid basin. CONCLUSION: This prospective case control study protocol will be used to launch a multicentre trial assessing the relationship between significant carotid stenosis and retinal perfusion measured with automated retinal oximetry. Despite these differences, the findings indicate the potential of retinal oximetry for noninvasive real-time measurements of oxyhaemoglobin saturation in central nervous system vessels. Following calibration upgrade and technological improvement, verification retinal oximetry may potentially be applied to critically ill and anaesthesia care patients. The study on combined scanning laser ophthalmoscope and retinal oximetry supports the feasibility of the technique for oximetry analysis in newly born babies. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT06085612.
Department of Neurology University Hospital Olomouc Olomouc Czech Republic
Department of Ophthalmology Central Military Hospital Prague Olomouc Czech Republic
Department of Ophthalmology University Hospital Olomouc Olomouc Czech Republic
See more in PubMed
Katan M, Luft A. Global Burden of Stroke. Semin Neurol 2018;38(2):208-11. DOI
Bryndziar T, Sedova P, Mikulík R. Incidence cévní mozkové příhody v Evropě - systematická review. Cesk Slov Neurol N 2017;113(2):180-9. (In Czech) DOI
Flaherty ML, Kissela B, Khoury JC, Alwell K, Moomaw CJ, Woo D, Khatri P, Ferioli S, Adeoye O, Broderick JP, Kleindorfer D. Carotid artery stenosis as a cause of stroke. Neuroepidemiology 2013;40(1):36-41. doi: 10.1159/000341410 PubMed DOI
Nadareishvili ZG, Rothwell PM, Beletsky V, Pagniello A, Norris JW. Long-term Risk of Stroke and Other Vascular Events in Patients With Asymptomatic Carotid Artery Stenosis. Arch Neurol 2002;59(7):1162-6. DOI
den Hartog AG, Achterberg S, Moll FL, Kappelle LJ, Visseren FL, van der Graaf Y, Algra A, de Borst GJ; SMART Study Group. Asymptomatic carotid artery stenosis and the risk of ischemic stroke according to subtype in patients with clinical manifest arterial disease. Stroke 2013;44(4):1002-7. DOI
Rothwell PM, Mehta Z, Howard SC, Gutnikov SA, Warlow CP. Treating individuals 3: from subgroups to individuals: general principles and the example of carotid endarterectomy. Lancet 2005;365(9455):256-65. DOI
Halliday A, Harrison M, Hayter E, Kong X, Mansfield A, Marro J, Pan H, Peto R, Potter J, Rahimi K, Rau A, Robertson S, Streifler J, Thomas D; Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group. 10-year stroke prevention after successful carotid endarterectomy for asymptomatic stenosis (ACST-1): a multicentre randomised trial. Lancet 2010;376(9746):1074-84. DOI
Park MS, Kwon S, Lee MJ, Kim KH, Jeon P, Park YJ, Kim DI, Kim YW, Bang OY, Chung CS, Lee KH, Kim GM. Identification of High Risk Carotid Artery Stenosis: A Multimodal Vascular and Perfusion Imaging Study. Front Neurol 2019;10:765. doi: 10.3389/fneur.2019.00765 PubMed DOI
Geirsdottir A, Palsson O, Hardarson SH, Olafsdottir OB, Kristjansdottir JV, Stefánsson E. Retinal vessel oxygen saturation in healthy individuals. Invest Ophthalmol Vis Sci 2012;53(9):5433-42. DOI
Eliasdottir TS, Bragason D, Hardarson SH, Vacchiano C, Gislason T, Kristjansdottir JV, Kristjansdottir G, Stefánsson E. Retinal oximetry measures systemic hypoxia in central nervous system vessels in chronic obstructive pulmonary disease. PLoS One 2017;12(3):e017402. DOI
Garg AK, Knight D, Lando L, Chao DL. Advances in Retinal Oximetry. Transl Vis Sci Technol 2021;10(2):5. DOI
Einarsdottir AB, Olafsdottir OB, Hjaltason H, Hardarson SH. Retinal oximetry is affected in multiple sclerosis. Acta Ophthalmol 2018;96(5):528-30. DOI
Einarsdottir AB, Hardarson SH, Kristjansdottir JV, Bragason DT, Snaedal J, Stefánsson E. Retinal oximetry imaging in Alzheimer's disease. J Alzheimers Dis 2016;49(1):79-83. DOI
Zhang W, Li L, Zou D, Ren Q, Zhang Y, Kang L, Gu X, Wu H, Zhang S, Zhu R, Zhang Y, Yang L. Retinal vessel oxygen saturation in patients with unilateral internal carotid artery stenosis: a pilot study. Acta Ophthalmol 2021;99(1):e13-e18. DOI
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;8(1):17161. DOI
Grant EG, Benson CB, Moneta GL, Alexandrov AV, Baker JD, Bluth EI, Carroll BA, Eliasziw M, Gocke J, Hertzberg BS, Katanick S, Needleman L, Pellerito J, Polak JF, Rholl KS, Wooster DL, Zierler RE. Carotid artery stenosis: gray-scale and Doppler US diagnosis-Society of Radiologists in Ultrasound Consensus Conference. Radiology 2003;229(2):340-6. DOI
Gerhard-Herman M, Gardin JM, Jaff M, Mohler E, Roman M, Naqvi TZ. Guidelines for Noninvasive Vascular Laboratory Testing: A Report from the American Society of Echocardiography and the Society of Vascular Medicine and Biology. J Am Soc Echocardiogr 2006;19:955-72. DOI
Bartels E. Transcranial color-coded duplex ultrasonography in routine cerebrovascular diagnostics. Perspect Med 2012;1(1-12):325-30. doi: 10.1016/j.permed.2012.06.001 DOI
Hammer M, Vilser W, Riemer T, Schweitzer D. Retinal vessel oximetry-calibration, compensation for vessel diameter and fundus pigmentation, and reproducibility. J Biomed Opt 2008;13(5):054015. doi: 10.1117/1.2976032 PubMed DOI
Narasimha-Iyer H, Mahadevan V, Beach JM, Roysam B. Improved detection of the central reflex in retinal vessels using a generalized dual-gaussian model and robust hypothesis testing. IEEE Trans Inf Technol Biomed 2008;12(3):406-10. DOI
ClinicalTrials.gov
NCT06085612
