Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease

NCT05082402 | Recruiting FDA Device

• 1 other identifier: STU00215189
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Retina; Change

Keywords

retinal vasculature; cardiovascular disease; swept source optical coherence tomography angiography; SS-OCTA; carotid duplex ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

All Participants

EXPERIMENTAL

50 participants identified in the Northwestern Medicine Division of Vascular Surgery.

Diagnostic Test: Swept Source Optical Coherence Tomography Angiography

Interventions

Swept Source Optical Coherence Tomography Angiography DIAGNOSTIC_TEST

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.

All Participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University/Northwestern Medical Group, Department of Ophthalmology

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (20)

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MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Rukhsana Mirza, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnold Nadel

CONTACT

224-436-3677; arnold.nadel@northwestern.edu

Clinical Research Office

CONTACT

312-503-4849; ophthoresearch@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, M.D., MS

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 19, 2021
• Study Start: August 17, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)