Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases; Retina; Change
• Interventions: Diagnostic Test: Swept Source Optical Coherence Tomography Angiography

• Registration Number: NCT05082402
• Lead Sponsor: Northwestern University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-08-17
• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-19
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Participants	Swept Source Optical Coherence Tomography Angiography	50 participants identified in the Northwestern Medicine Division of Vascular Surgery.

Primary Outcome Measures

Name	Time	Method
Correlation with and prediction of the presence/degree of carotid occlusive disease as determined by carotid duplex ultrasonography	2 hours	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.

Trial Locations

Locations (1)

Northwestern University/Northwestern Medical Group, Department of Ophthalmology; 🇺🇸 Chicago, Illinois, United States