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

Primary Purpose

Cardiovascular Abnormalities, Vascular Diseases, Retinal Vascular

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ophthalmologic consultation
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Abnormalities

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients eligible for a calcium score as part of their standard treatment and volunteers for an ophthalmologic consultation Exclusion Criteria: Pregnant women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ophthalmology consultation

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 14, 2022
    Last Updated
    November 21, 2022
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05624255
    Brief Title
    Correlating the Measure of Retinal Vascular Density Through Angio-OCT With Calcium Score
    Acronym
    ANOSCA
    Official Title
    Correlating the Measure of Retinal Vascular Density Through Angio-OCT With Calcium Score
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2022 (Anticipated)
    Primary Completion Date
    May 2024 (Anticipated)
    Study Completion Date
    May 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Abnormalities, Vascular Diseases, Retinal Vascular

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ophthalmology consultation
    Arm Type
    Experimental
    Arm Description
    Patients eligible to calcium score will be offered an ophthalmologic consultation including Angio-Optical Coherence Tomography [OCT]
    Intervention Type
    Other
    Intervention Name(s)
    Ophthalmologic consultation
    Intervention Description
    Complete ophthalmologic examination including angio-OCT
    Primary Outcome Measure Information:
    Title
    Correlation between retinal vascular density and calcium score
    Description
    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
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients eligible for a calcium score as part of their standard treatment and volunteers for an ophthalmologic consultation Exclusion Criteria: Pregnant women
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Valentin WETZEL, Int
    Phone
    0033381664417
    Email
    wetzel.valentin70@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anne-Sophie GAUTHIER, MD PhD
    Email
    asgauthier@chu-besancon.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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