High Resolution Imaging of Retinal Vessels as a Biomarker of Cardiovascular Disease in Patients With Renal Insufficiency - RI

Renal Insufficiency Clinical Trial

— IRIR  

Official title:

High Resolution Imaging of Retinal Vessels as a Biomarker of Cardiovascular Disease in Patients With Renal Insufficiency - (IRIR)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04116814
• Other study ID #: 2017-A03143-50
• Status: Active, not recruiting
• Start date: April 21, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: October 2019
• Source: Ramsay Générale de Santé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: March 31, 2022
• Est. primary completion date: March 29, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Biomarker
• Cardiovascular Diseases
• Renal Insufficiency
• Retinal Imaging

Intervention

Diagnostic Test:
• wall-to-lumen ratio measurement
wall-to-lumen ratio measurement in patients with renal insufficiency

Locations

Country	Name	City	State
France	Saint Martin Private Hospital	Caen	Normandy

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	Dr Céline FAURE

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictibilty of WLR	The primary endpoint is time to event (cardiovascular events or death) in months, assessed by survival analysis.	3 years
Secondary	WLR associated biomarker	Secondary endpoints: - Association between WLR and cardiovascular risk factors, medical history and metabolic parameters.	3 years