Clinical trial NCT03270358: OStéopontin as a Marker Of StenoSIS - OSMOSIS
Official title: OStéopontin as a Marker Of StenoSIS - OSMOSIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stenosis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Our hypothesis is that a plasma protein named osteopontin (OPN) could serve as a biological predictive marker of acute AVF dysfunction. In several scientific studies, plasma OPN was correlated with coronary stent restenosis, and with cardiovascular outcome in patients with diabetes and renal insufficiency. This protein is secreted by several cellular types, like distal tubule epithelial cells, macrophages, but also fibroblasts and cardiac and vascular endothelial cells, in response to several specific stimuli. It acts like a cytokine, inducing immunological mechanisms as well as tissue remodeling.

The main objective of this study is to show that the amount of plasma OPN is higher in patients presenting with an AVF stenosis, compared with patients with a functioning AVF.

OSMOSIS is a monocentric pilot study that will include patients into two groups during 12 months (no specific follow-up). The control group will include patients that have been dialyzed on an AVF, in the dialysis center of Nice University Hospital, for at least 3 months without any incident. The experimental group will include hemodialysis patients hospitalized in the department of vascular surgery for acute AVF dysfunction, needing endovascular or open surgical revision for venous stenosis.

Blood will be withdrawn right before dialysis or surgical procedure. Plasma OPN will me measured by ELISA. Their clinical data would be collected from medical file at the same time. After the procedure, patients will be followed-up according to usual protocols.

To show a significant difference of 100ng/mL plasma OPN between the two groups, with a power of 90% and alpha risk of 0.05, we plan to include 76 patients


Eligibility criteria: Inclusion Criteria:

* Patients under a social security scheme
* Written informed consent obtain
* 18 years old or older
* end-stage renal failure disease with 3 months dialysis minimum on a native arteriovenous fistula

Non-inclusion Criteria:

* Subject under juridicial protection
* Pregnant or lactating women
* Subject already enrolled in a clinical trial involving a drug or an implantable medical device

Exclusion Criteria:

* Withdrawal of consent
* Investigator or sponsor decision

Primary outcomes:
measure: Plasmatic osteopontin level
timeFrame: at inclusion
Secondary outcomes:
measure: Peripheral plasmatic osteopontin level in the contralateral arm
timeFrame: at inclusion
measure: Peripheral plasmatic osteopontin level in the contralateral arm
timeFrame: at inclusion
measure: Peripheral plasmatic osteopontin level in the contralateral arm
timeFrame: at inclusion
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Service de chirurgie vasculaire
Study officials:
affiliation: sadaghianloo.n@chu-nice.fr
name: Nirvana SADAGHIANLOO
role: PRINCIPAL_INVESTIGATOR
References: