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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05624255
Other study ID # 2022/701
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2022
Est. completion date May 2024

Study information

Verified date November 2022
Source Centre Hospitalier Universitaire de Besancon
Contact Valentin WETZEL, Int
Phone 0033381664417
Email wetzel.valentin70@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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 Design


Intervention

Other:
Ophthalmologic consultation
Complete ophthalmologic examination including angio-OCT

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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