ANOSCA: Correlating the Measure of Retinal Vascular Density Through Angio-OCT With Calcium Score

• Sponsor: Centre Hospitalier Universitaire de Besancon (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05624255
• Collaborator: (none)
• Enrollment: 100
• Arm: 1
• Anticipated Duration (Months): 18

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Abnormalities; Vascular Diseases; Retinal Vascular	Other: Ophthalmologic consultation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Correlating the Measure of Retinal Vascular Density Through Angio-OCT With Calcium Score
• Anticipated Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Correlation between retinal vascular density and calcium score [Day 1]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant women

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Besancon
• ClinicalTrials.gov Identifier: NCT05624255
• Other Study ID Numbers: 2022/701
• First Posted: Nov 22, 2022
• Last Update Posted: Nov 25, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Vascular Diseases; Cardiovascular Abnormalities

Study Results

No Results Posted as of Nov 25, 2022