Correlating the Measure of Retinal Vascular Density Through Angio-OCT with Calcium Score (ANOSCA)

Recent case-control studies have proven that the retinal vascularization mirrors the cardiac vascularization: more the coronary network is altered, more the density of retinal vessels is reduced. No studies have yet been realised in primary prevention. This study aims to demonstrate a link between the density of the retinal vascularization and the calcium score, which is currently the gold standard for the classification of cardiovascular risk in primary prevention. Thus, a simple image of the retinal vascularization could predict the cardiovascular risk of a patient. OCT angiography would become a major aid in the classification of cardiovascular risk in asymptomatic patients.

Study Overview

• Status: Completed
• Conditions: Vascular Diseases; Cardiovascular Abnormalities; Retinal Vascular
• Intervention / Treatment: Other: Ophthalmologic consultation

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • CHU de Besançon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients eligible for a calcium score as part of their standard treatment and volunteers for an ophthalmologic consultation

Exclusion Criteria:

• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ophthalmology consultation; Patients eligible to calcium score will be offered an ophthalmologic consultation including Angio-Optical Coherence Tomography [OCT]	Other: Ophthalmologic consultation; Complete ophthalmologic examination including angio-OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between retinal vascular density and calcium score	Comparison between values of calcium score and presence of vascular abnormalities in retina. Calcium is scored as follows: Coronary Artery Calcium [CAC] = 0 : very low risk; CAC = [1-100[ : low risk; CAC = [100-400[ : moderate risque; CAC = [400-1000[ : high risk; CAC = > 1000 : very high risk	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): March 16, 2023
• Study Completion (Actual): March 16, 2023

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Vascular Diseases; Cardiovascular Abnormalities
• Other Study ID Numbers: 2022/701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No