Clinical trial NCT04116814: High Resolution Imaging of Retinal Vessels as a Biomarker of Cardiovascular Disease in Patients With Renal Insufficiency - RI
Official title: High Resolution Imaging of Retinal Vessels as a Biomarker of Cardiovascular Disease in Patients With Renal Insufficiency - (IRIR)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinal Imaging
Cardiovascular Biomarker
Renal Insufficiency
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: Dr Céline FAURE
First posted: 2019-10-07
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient included with Ophthalmological examination with WLR measurement in adaptive optics

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Predictibilty of WLR
timeFrame: 3 years
Secondary outcomes:
measure: WLR associated biomarker
timeFrame: 3 years
Other outcomes:
Locations:
city: Caen
country: France
facility: Saint Martin Private Hospital
state: Normandy
Study officials:
References: