Cardiovascular AbnormalitiesANOSCANCT05624255
Correlating the Measure of Retinal Vascular Density Through Angio-OCT with Calcium Score
A study testing Ophthalmologic consultation in people with Cardiovascular Abnormalities and Vascular Diseases, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cardiovascular Abnormalities, Vascular Diseases, Retinal Vascular
- What is being tested?
- Ophthalmologic consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2022to 16 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for a calcium score as part of their standard treatment and volunteers for an ophthalmologic consultation
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Ophthalmologic consultation
- Medical subject headings
- Cardiovascular Abnormalities, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmologic consultationOther
Complete ophthalmologic examination including angio-OCT
| Study group | Role | What they receive |
|---|---|---|
| ophthalmology consultation | Experimental | Patients eligible to calcium score will be offered an ophthalmologic consultation including Angio-Optical Coherence Tomography [OCT] Receives: Other: Ophthalmologic consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start15 Dec 2022
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624255
- Sponsor's protocol ID
- 2022/701
- Acronym
- ANOSCA
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2022
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlating the Measure of Retinal Vascular Density Through Angio-OCT with Calcium Score
- ClinicalTrials.gov ID
- NCT05624255
- Acronym / sponsor ID
- ANOSCA / 2022/701
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 22 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ophthalmology consultation | Experimental | Other: Ophthalmologic consultationPatients eligible to calcium score will be offered an ophthalmologic consultation including Angio-Optical Coherence Tomography [OCT] |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients eligible for a calcium score as part of their standard treatment and volunteers for an ophthalmologic consultation
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophthalmologic consultationComplete ophthalmologic examination including angio-OCT | Other | ophthalmology consultation |
Primary outcome
Correlation between retinal vascular density and calcium score
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ophthalmologic consultation in people with Cardiovascular Abnormalities and Vascular Diseases, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between retinal vascular density and calcium score (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.