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

NCT04116814 | Unknown DMC

• 1 other identifier: 2017-A03143-50
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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).

Conditions

Retinal Imaging; Cardiovascular Biomarker; Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• Predictibilty of WLR

  The primary endpoint is time to event (cardiovascular events or death) in months, assessed by survival analysis.

  3 years

Secondary Outcomes (1)

• WLR associated biomarker

  3 years

Interventions

wall-to-lumen ratio measurement DIAGNOSTIC_TEST

wall-to-lumen ratio measurement in patients with renal insufficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patient included with Ophthalmological examination with WLR measurement in adaptive optics

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• Dr Céline FAURE: collaborator

Study Sites (1)

Saint Martin Private Hospital

Caen, Normandy, 14050, France

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: April 21, 2018
• Primary Completion: March 29, 2022
• Study Completion: March 31, 2022
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

FR (1)