Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease

Sponsor

Northwestern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05082402

Collaborator

(none)

Enrollment

Location

Arm

23.5

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Retina; Change	Diagnostic Test: Swept Source Optical Coherence Tomography Angiography	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Imaging of Retinochoroidal Vasculature in Patients Being Assessed for Cardiovascular Disease

Actual Study Start Date :

Aug 17, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All Participants 50 participants identified in the Northwestern Medicine Division of Vascular Surgery.	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.

Arm

Intervention/Treatment

Experimental: All Participants

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

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University/Northwestern Medical Group, Department of Ophthalmology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator: Rukhsana Mirza, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Rukhsana Mirza, Principal Investigator, M.D., MS, Northwestern University

ClinicalTrials.gov Identifier:

NCT05082402

Other Study ID Numbers:

STU00215189

First Posted:

Oct 19, 2021

Last Update Posted:

Nov 3, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Rukhsana Mirza, Principal Investigator, M.D., MS, Northwestern University

retinal vasculature

cardiovascular disease

swept source optical coherence tomography angiography

SS-OCTA

carotid duplex ultrasonography

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Nov 3, 2021