Systemic Vascular DamageOCTAVANCT06613555
Retinal Microvascularization in OCT-angiography and Systemic Diseases
An observational study of Systemic Vascular Damage, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Systemic diseases are inflammatory, chronic illnesses affecting different organs and altering their function. At present, there are few non-invasive methods for predicting their onset and progression. Some chronic diseases can be anticipated earlier thanks to predictive indicators. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Vascular Damage
- What is being tested?
- Retinal imaging and Biological check-up
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2024to Jun 2044
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with systemic vascular disease
Who may be able to join
- For the \"patients with systemic vascular disease\" group
- Patients who have given oral, free and informed consent
- Patients with either :
- systemic vascular pathology
- high cardiovascular risk
- inflammatory vascular pathology
Show all 14Show fewer
- preeclampsia during pregnancy
- The study will also be offered to patients who have already had an OCT-A examination as part of their routine care, in order to follow them over time.
- For the \"healthy control\" group
- Patients who have given free, oral and informed consent
- Patients with no prior systemic or vascular inflammatory pathology, and no high cardiovascular risk
- Non-diabetic patients
- Pregnant patients with risk-free pregnancies recruited from the gynecology department of CHU Dijon Bourgogne OR
- Adult patients without maculopathy recruited from the Ophthalmology Department of CHU Dijon Bourgogne
Who cannot join
- For the \"patients with systemic vascular disease\" group
- Ophthalmological history in both eyes (vascular and degenerative macular pathologies)
- Protected patient :
- Minor patient
- Patient under legal protection (guardianship, curatorship, court order)
- Patient unable to give consent Person not affiliated to a social security scheme
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- Breast-feeding women
- Person with a contraindication to Tropicamide
- OCT-A signal strength \< 7
- For the \"healthy control\" group
- Any pathology studied in the case group
- Ophthalmological history in both eyes (vascular and degenerative macular pathologies)
- Type 1 or type 2 diabetes
- Person with a contraindication to Tropicamide
- Protected person :
- Minor
- Person under legal protection (guardianship, curatorship, court order)
- Person unable to give consent
- Person not affiliated to a social security scheme
- Breast-feeding women
- OCT-A signal strength \< 7
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourogne
Dijon, 21000
Laure-Anne Steinberg, 0380281324, laure-anne.steinberg@chu-dijon.fr
About this study
Systemic diseases are inflammatory, chronic illnesses affecting different organs and altering their function. At present, there are few non-invasive methods for predicting their onset and progression.
Some chronic diseases can be anticipated earlier thanks to predictive indicators. These indicators could help doctors decide which treatment is best suited to each patient. In particular, the state of microcirculation in the eyes, specifically in the retina, is linked to the progression of certain diseases in the body. Unfortunately, assessing the health of the small blood vessels in the retina is complicated. Most current methods are imprecise, difficult to reproduce and require qualified specialists. However, the use of retinal microcirculation appears to be a promising approach to solving these problems.
Read more
In fact, the structure of retinal blood vessels can be observed easily, painlessly and without invasive procedures, thanks to fundus photographs or scans providing imaging slices known as optical coherence tomography-angiography (OCT-A).
The vascularization of the retina is very often presented as a window giving access to the peripheral vascularization (the vascularization of other organs distant from the eyes).
For example, we recently demonstrated a link between retinal vascularization and the risk of heart problems in patients with coronary artery disease.
The aim of this study is to gather original information on the evolution of retinal vascularization, using specific markers that may be associated with damage to distant organs.
By regularly monitoring these changes over time, the researchers hope to identify early changes that could indicate the development or evolution of these diseases.
The main aim of this study is to create a database of images obtained by OCT-Angiography in patients with systemic diseases and in healthy individuals. This will enable us to identify early changes in retinal vascularization that may be associated with these systemic pathologies.
With this information, we hope to improve early diagnosis and monitoring of diseases, which could have a positive impact on patients\' health.
- Conditions
- Systemic Vascular Damage
- Being tested
- Retinal imaging, Biological check-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal imagingOther
the retinal imaging work-up includes:
- OCT-angiography
- Retinophotography
- Adaptive optics performed at inclusion, at 6 months and then once a year for 10 years for patients Only performed at inclusion for controls
Biological check-upBiological
it is performed at inclusion and then once a year for 10 years for patients
Only performed at inclusion for controls
| Study group | Role | What they receive |
|---|---|---|
| patients with systemic vascular disease | * patients with either:
* systemic vascular pathology
* high cardiovascular risk
* inflammatory vascular pathology
* preeclampsia during pregnancy Receives: Other: Retinal imaging; Biological: Biological check-up | |
| healthy controls | patients with no systemic or vascular inflammatory pathology and no high cardiovascular risk Receives: Other: Retinal imaging; Biological: Biological check-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the evolution of retinal microvascular densities in OCT-A
Measured: Up to 10 years
Comparison of the clinical course of patients with systemic pathologies
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start19 Jun 2024
- Primary completionJun 2044 (estimated)
- Study completionJun 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Vascular DamageStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613555
- Sponsor's protocol ID
- ARNOULD 2022
- Acronym
- OCTAVA
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Microvascularization in OCT-angiography and Systemic Diseases
- ClinicalTrials.gov ID
- NCT06613555
- Acronym / sponsor ID
- OCTAVA / ARNOULD 2022
- Conditions
- Systemic Vascular Damage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- Jun 2044 (estimated)
- Study completion
- Jun 2044 (estimated)
- First posted
- 26 Sep 2024 (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.
Systemic diseases are inflammatory, chronic illnesses affecting different organs and altering their function. At present, there are few non-invasive methods for predicting their onset and progression.
Some chronic diseases can be anticipated earlier thanks to predictive indicators. These indicators could help doctors decide which treatment is best suited to each patient. In particular, the state of microcirculation in the eyes, specifically in the retina, is linked to the progression of certain diseases in the body. Unfortunately, assessing the health of the small blood vessels in the retina is complicated. Most current methods are imprecise, difficult to reproduce and require qualified specialists. However, the use of retinal microcirculation appears to be a promising approach to solving these problems.
In fact, the structure of retinal blood vessels can be observed easily, painlessly and without invasive procedures, thanks to fundus photographs or scans providing imaging slices known as optical coherence tomography-angiography (OCT-A).
The vascularization of the retina is very often presented as a window giving access to the peripheral vascularization (the vascularization of other organs distant from the eyes).
For example, we recently demonstrated a link between retinal vascularization and the risk of heart problems in patients with coronary artery disease.
The aim of this study is to gather original information on the evolution of retinal vascularization, using specific markers that may be associated with damage to distant organs.
By regularly monitoring these changes over time, the researchers hope to identify early changes that could indicate the development or evolution of these diseases.
The main aim of this study is to create a database of images obtained by OCT-Angiography in patients with systemic diseases and in healthy individuals. This will enable us to identify early changes in retinal vascularization that may be associated with these systemic pathologies.
With this information, we hope to improve early diagnosis and monitoring of diseases, which could have a positive impact on patients\' health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with systemic vascular disease | – | Other: Retinal imaging, Biological: Biological check-up* patients with either: * systemic vascular pathology * high cardiovascular risk * inflammatory vascular pathology * preeclampsia during pregnancy |
| healthy controls | – | Other: Retinal imaging, Biological: Biological check-uppatients with no systemic or vascular inflammatory pathology and no high cardiovascular risk |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic vascular disease
Key inclusion criteria (14 listed)
- For the \"patients with systemic vascular disease\" group
- Patients who have given oral, free and informed consent
- Patients with either :
- The study will also be offered to patients who have already had an OCT-A examination as part of their routine care, in order to follow them over time.
- For the \"healthy control\" group
Key exclusion criteria (21 listed)
- For the \"patients with systemic vascular disease\" group
- Ophthalmological history in both eyes (vascular and degenerative macular pathologies)
- Protected patient :
- Person with a contraindication to Tropicamide
- OCT-A signal strength \< 7
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 |
|---|---|---|
| Retinal imagingthe retinal imaging work-up includes: * OCT-angiography * Retinophotography * Adaptive optics performed at inclusion, at 6 months and then once a year for 10 years for patients Only performed at inclusion for controls | Other | healthy controls, patients with systemic vascular disease |
| Biological check-upit is performed at inclusion and then once a year for 10 years for patients Only performed at inclusion for controls | Biological | healthy controls, patients with systemic vascular disease |
Primary outcome
Comparison of the evolution of retinal microvascular densities in OCT-A
Time frame: Up to 10 years
Comparison of the clinical course of patients with systemic pathologies
Time frame: Up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Vascular Damage, run by Centre Hospitalier Universitaire Dijon 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 14 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 26 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louis ARNOULD (0380293453, Louis.arnould@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the evolution of retinal microvascular densities in OCT-A (time frame: Up to 10 years). The study lists 2 primary outcomes in all. 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 26 Sep 2024.