Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease

Cardiovascular Diseases Clinical Trial

Official title:

Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05082402
• Other study ID #: STU00215189
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Arnold Nadel
• Phone: 224-436-3677
• Email: arnold.nadel[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to determine whether changes in retinal vasculature seen on SS-OCTA can be correlated to degree of cardiovascular disease as measured by carotid duplex ultrasonography.

Description:

The study's primary objective is to determine whether measures taken from SS-OCTA, color fundus photography, and retinal exams can correlate with and predict the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography by examining the following parameters: retinal vessel caliber, retinal vessel density, retinal vessel perfusion, retinal vessel tortuosity, presence of Hollenhorst or other plaques, and/or areas of ischemia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subjects between 18 and 80 years of age.
• No known prior history of retinal disease.
• Able to participate in a clinical eye examination setting.
• Able to consent.
• Subjects receiving standard of care carotid duplex ultrasounds.

Exclusion Criteria:

• Known ophthalmologic disease (e.g. glaucoma, macular degeneration, ocular injury) other than corrected refractive error.
• Lack of capacity to provide informed consent.
• Subjects younger than 18 years of age or older than 80 years of age.
• History of stroke or acute loss of vision.
• Unable to participate in a clinical eye examination setting.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Retina; Change

Intervention

Diagnostic Test:
• Swept Source Optical Coherence Tomography Angiography
The PLEX Elite 9000 is an FDA cleared research device for use in ocular imaging obtained by Northwestern University by way of a purchase agreement with the manufacturer, Carl Zeiss Meditec, Inc. It is currently unavailable outside of participation in the ARI Network, a cloudbased storage and image processing platform using deidentified information shared between academic institutions. The ARI Network is managed by a group of physicians and scientists from around the world that are working to better understand eye diseases.

Locations

Country	Name	City	State
United States	Northwestern University/Northwestern Medical Group, Department of Ophthalmology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (20)

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Kadian-Dodov D, Papolos A, Olin JW. Diagnostic utility of carotid artery duplex ultrasonography in the evaluation of syncope: a good test ordered for the wrong reason. Eur Heart J Cardiovasc Imaging. 2015 Jun;16(6):621-5. doi: 10.1093/ehjci/jeu315. Epub 2015 Feb 10. — View Citation

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. — View Citation

Liew G, Mitchell P, Chiha J, Plant AJH, White A, Joachim N, Wang S, Burlutsky G, Kovoor P, Thiagalingam A, Gopinath B. Retinal microvascular changes in microvascular angina: Findings from the Australian Heart Eye Study. Microcirculation. 2019 Aug;26(6):e12536. doi: 10.1111/micc.12536. Epub 2019 Mar 20. — View Citation

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Phan K, Mitchell P, Liew G, Plant AJ, Wang SB, Au C, Chiha J, Kovoor P, Thiagalingam A, Burlutsky G, Gopinath B. Association between Retinal Arteriolar and Venule Calibre with Prevalent Heart Failure: A Cross-Sectional Study. PLoS One. 2015 Dec 11;10(12):e0144850. doi: 10.1371/journal.pone.0144850. eCollection 2015. — View Citation

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Wang J, Jiang J, Zhang Y, Qian YW, Zhang JF, Wang ZL. Retinal and choroidal vascular changes in coronary heart disease: an optical coherence tomography angiography study. Biomed Opt Express. 2019 Mar 4;10(4):1532-1544. doi: 10.1364/BOE.10.001532. eCollection 2019 Apr 1. — View Citation

Wang L, Wong TY, Sharrett AR, Klein R, Folsom AR, Jerosch-Herold M. Relationship between retinal arteriolar narrowing and myocardial perfusion: multi-ethnic study of atherosclerosis. Hypertension. 2008 Jan;51(1):119-26. doi: 10.1161/HYPERTENSIONAHA.107.098343. Epub 2007 Nov 12. — View Citation

Wang SB, Mitchell P, Liew G, Wong TY, Phan K, Thiagalingam A, Joachim N, Burlutsky G, Gopinath B. A spectrum of retinal vasculature measures and coronary artery disease. Atherosclerosis. 2018 Jan;268:215-224. doi: 10.1016/j.atherosclerosis.2017.10.008. Epub 2017 Oct 10. — View Citation

Wang SB, Mitchell P, Plant AJ, Phan K, Liew G, Thiagalingam A, Burlutsky G, Gopinath B. Metabolic syndrome and retinal microvascular calibre in a high cardiovascular disease risk cohort. Br J Ophthalmol. 2016 Aug;100(8):1041-6. doi: 10.1136/bjophthalmol-2015-307637. Epub 2015 Nov 3. — View Citation

Wong TY, Cheung N, Islam FM, Klein R, Criqui MH, Cotch MF, Carr JJ, Klein BE, Sharrett AR. Relation of retinopathy to coronary artery calcification: the multi-ethnic study of atherosclerosis. Am J Epidemiol. 2008 Jan 1;167(1):51-8. doi: 10.1093/aje/kwm256. Epub 2007 Sep 24. — View Citation

Wong TY, Klein R, Klein BE, Tielsch JM, Hubbard L, Nieto FJ. Retinal microvascular abnormalities and their relationship with hypertension, cardiovascular disease, and mortality. Surv Ophthalmol. 2001 Jul-Aug;46(1):59-80. doi: 10.1016/s0039-6257(01)00234-x. — View Citation

Zhao Y, Yang K, Wang F, Liang Y, Peng Y, Shen R, Wong T, Wang N. Associations between metabolic syndrome and syndrome components and retinal microvascular signs in a rural Chinese population: the Handan Eye Study. Graefes Arch Clin Exp Ophthalmol. 2012 Dec;250(12):1755-63. doi: 10.1007/s00417-012-2109-2. Epub 2012 Sep 5. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation with and prediction of the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography	Determining whether measures taken from SS-OCTA, color fundus photography, and retinal exams can correlate with and predict the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography by examining the following parameters: retinal vessel caliber, retinal vessel density, retinal vessel perfusion, retinal vessel tortuosity, presence of Hellenhorst or other plaques, and/or areas of ischemia.	2 hours