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

NCT05624255 | Completed

• 1 other identifier: 2022/701
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Abnormalities; Vascular Diseases; Retinal Vascular

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

ophthalmology consultation

EXPERIMENTAL

Patients eligible to calcium score will be offered an ophthalmologic consultation including Angio-Optical Coherence Tomography \[OCT\]

Other: Ophthalmologic consultation

Interventions

Ophthalmologic consultation OTHER

Complete ophthalmologic examination including angio-OCT

ophthalmology consultation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Cardiovascular Abnormalities; Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 22, 2022
• Study Start: December 15, 2022
• Primary Completion: March 16, 2023
• Study Completion: March 16, 2023
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)