Retinal ImagingIRIRNCT04116814
High Resolution Imaging of Retinal Vessels as a Biomarker of Cardiovascular Disease in Patients With Renal Insufficiency - RI
An observational study of Retinal Imaging and Cardiovascular Biomarker, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The objectives are to better understand, in the dialysis patient, the relationships between microvascular morphometry and cardiovascular events, survival, arterial hypertension, the pathology responsible for renal failure, the age of dialysis and metabolic parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Imaging, Cardiovascular Biomarker, Renal Insufficiency
- What is being tested?
- wall-to-lumen ratio measurement
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2018to 31 Mar 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All patient included with Ophthalmological examination with WLR measurement in adaptive optics
Who may be able to join
- Adult
- Patients with renal insufficiency: waiting for management (dialysis or transplant), during dialysis or after a kidney transplant followed in the nephrology department of the Saint Martin clinic.
- First examination in adaptive optics giving a usable result (possibility of measuring the WLR)
- Affiliate or beneficiary of a social security scheme
- Patient having given their free and informed consent
Who cannot join
- Protected patients: adults under guardianship, trusteeship or other legal protection, deprived of liberty by judicial or administrative decision, hospitalised without consent.
- Pregnant, lactating or parturient women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Resolution Imaging of Retinal Vessels as a Biomarker of Cardiovascular Disease in Patients With Renal Insufficiency - (IRIR)
The objectives are to better understand, in the dialysis patient, the relationships between microvascular morphometry and cardiovascular events, survival, arterial hypertension, the pathology responsible for renal failure, the age of dialysis and metabolic parameters.
The investigator team also want to better understand the relationship between the diameter of small arteries and parameters such as hypertension, the pathology that causes kidney failure, the age of dialysis, the use of VKA or EPO, metabolic parameters (HbA1c, NFS, reticulocytes, BNP, lipid balance, phosphocalcic balance).
Read the detailed description
The cardiovascular morbidity of a dialysis patient is 10 times higher than that of a subject in the general population. The patient with renal insufficiency is therefore at high cardiovascular risk. An increase in the wall-to-lumen ratio (WLR) is an early sign of microvascular damage, predictive of the risk of a cardiovascular event. The benefits of WLR measurement are therefore at the level of both the diagnosis and prognosis of vascular disease. Recently, a fundus camera coupled with an adaptive optics system has been able to measure for the first time in vivo non-invasively and reproducibly the wall thickness of the small arteries of the retina, and therefore the WLR, among other biomarkers relating to microvascular remodelling.
Studies in hypertension have confirmed that the rtX1 camera allows reliable and reproducible measurements of the WLR. The main aim of our study is to evaluate the value of the WLR as a biomarker of the risk of cardiovascular morbidity and mortality in patients with renal insufficiency.
The objectives are to better understand, in the dialysis patient, the relationships between microvascular morphometry and cardiovascular events, survival, arterial hypertension, the pathology responsible for renal failure, the age of dialysis and metabolic parameters.
The investigator team also want to better understand the relationship between the diameter of small arteries and parameters such as hypertension, the pathology that causes kidney failure, the age of dialysis, the use of VKA or EPO, metabolic parameters (HbA1c, NFS, reticulocytes, BNP, lipid balance, phosphocalcic balance).
- Being tested
- wall-to-lumen ratio measurement
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wall-to-lumen ratio measurementDiagnostic test
wall-to-lumen ratio measurement in patients with renal insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictibilty of WLR
The primary endpoint is time to event (cardiovascular events or death) in months, assessed by survival analysis.
Measured: 3 years
Secondary outcomes (1)
WLR associated biomarker
Secondary endpoints:
- Association between WLR and cardiovascular risk factors, medical history and metabolic parameters.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start21 Apr 2018
- Primary completion29 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal ImagingStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- 83 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Céline FAURE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116814
- Sponsor's protocol ID
- 2017-A03143-50
- Acronym
- IRIR
- Status last verified
- Oct 2019
- First submitted
- 3 Oct 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Imaging of Retinal Vessels as a Biomarker of Cardiovascular Disease in Patients With Renal Insufficiency - (IRIR)
- ClinicalTrials.gov ID
- NCT04116814
- Acronym / sponsor ID
- IRIR / 2017-A03143-50
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Dr Céline FAURE
- Study start
- 21 Apr 2018 (actual)
- Primary completion
- 29 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 7 Oct 2019 (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.
The objectives are to better understand, in the dialysis patient, the relationships between microvascular morphometry and cardiovascular events, survival, arterial hypertension, the pathology responsible for renal failure, the age of dialysis and metabolic parameters.
The investigator team also want to better understand the relationship between the diameter of small arteries and parameters such as hypertension, the pathology that causes kidney failure, the age of dialysis, the use of VKA or EPO, metabolic parameters (HbA1c, NFS, reticulocytes, BNP, lipid balance, phosphocalcic balance).
Detailed description
The cardiovascular morbidity of a dialysis patient is 10 times higher than that of a subject in the general population. The patient with renal insufficiency is therefore at high cardiovascular risk. An increase in the wall-to-lumen ratio (WLR) is an early sign of microvascular damage, predictive of the risk of a cardiovascular event. The benefits of WLR measurement are therefore at the level of both the diagnosis and prognosis of vascular disease. Recently, a fundus camera coupled with an adaptive optics system has been able to measure for the first time in vivo non-invasively and reproducibly the wall thickness of the small arteries of the retina, and therefore the WLR, among other biomarkers relating to microvascular remodelling.
Studies in hypertension have confirmed that the rtX1 camera allows reliable and reproducible measurements of the WLR. The main aim of our study is to evaluate the value of the WLR as a biomarker of the risk of cardiovascular morbidity and mortality in patients with renal insufficiency.
The objectives are to better understand, in the dialysis patient, the relationships between microvascular morphometry and cardiovascular events, survival, arterial hypertension, the pathology responsible for renal failure, the age of dialysis and metabolic parameters.
The investigator team also want to better understand the relationship between the diameter of small arteries and parameters such as hypertension, the pathology that causes kidney failure, the age of dialysis, the use of VKA or EPO, metabolic parameters (HbA1c, NFS, reticulocytes, BNP, lipid balance, phosphocalcic balance).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patient included with Ophthalmological examination with WLR measurement in adaptive optics
Key inclusion criteria (5 listed)
- Adult
- Patients with renal insufficiency: waiting for management (dialysis or transplant), during dialysis or after a kidney transplant followed in the nephrology department of the Saint Martin clinic.
- First examination in adaptive optics giving a usable result (possibility of measuring the WLR)
- Affiliate or beneficiary of a social security scheme
- Patient having given their free and informed consent
Key exclusion criteria (2 listed)
- Protected patients: adults under guardianship, trusteeship or other legal protection, deprived of liberty by judicial or administrative decision, hospitalised without consent.
- Pregnant, lactating or parturient 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 |
|---|---|---|
| wall-to-lumen ratio measurementwall-to-lumen ratio measurement in patients with renal insufficiency | Diagnostic test | – |
Primary outcome
Predictibilty of WLR
Time frame: 3 years
The primary endpoint is time to event (cardiovascular events or death) in months, assessed by survival analysis.
1 secondary outcome
WLR associated biomarker
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Retinal Imaging and Cardiovascular Biomarker, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Oct 2019. 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?
Results are not available in the source record.
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?
Predictibilty of WLR (time frame: 3 years). 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 10 Oct 2019.