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Clinical Trials/NCT05017649
NCT05017649
Recruiting
Not Applicable

Characterization of Adenosine A2A Receptor Expression and Fubnction in Hypercholesterolemic Patients

Assistance Publique Hopitaux De Marseille1 site in 1 country150 target enrollmentSeptember 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypercholesterolemia
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
150
Locations
1
Primary Endpoint
Quantification of A2AR expression in PBMCs
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Hypercholesterolemia promotes chronic inflammation, endothelial dysfunction, atherosclerosis and is a major risk factor for cardiovascular disease (CVD). Treatment with lipid-lowering drugs (statins, ezetimibe, PCSK9 inhibitors or LDL-apheresis) reduces the risk of major cardiovascular events in proportion to the absolute reduction of LDL-cholesterol (LDL-C). Nevertheless, a better understanding of the effects of hypercholesterolemia on the cardiovascular and immune systems could help identify all the mechanisms responsible for the excess risk of CVD in hypercholesterolemic patients and develop better prevention and treatment strategies.

Adenosine via A2A receptors (A2AR) plays a crucial role in the regulation of the cardiovascular and immune systems.

In this project, the investigators wish :

  • To study whether the expression and function of A2AR in PBMCs are altered in human hypercholesterolemia, using as a study model a larger cohort of patients with hypercholesterolemia of increasing level and severity: polygenic form, heterozygous genetic form and homozygous genetic form in comparison with healthy subjects with normal cholesterol levels.
  • To study whether A2AR expression and function in PBMCs are associated with blood levels of LDL-C and homocysteine and with the inflammatory status of patients.
  • To assess whether the cholesterol-lowering therapies currently used to reduce LDL-C levels and thus the risk of CVD in hypercholesterolemic patients have an impact on possible alterations of A2AR expression and function in PBMCs.
Registry
clinicaltrials.gov
Start Date
September 20, 2021
End Date
June 19, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male or female subjects aged 18-80 years
  • For the group of hypercholesterolemic patients :
  • LDL-cholesterol level \>1.9 g/L with or without treatment to make the diagnosis of hypercholesterolemia (laboratory test less than 12 months old at inclusion)
  • For the healthy group :
  • ● No cholesterol-modifying therapy.
  • Subject not having hypercholesterolemia (biological assessment less than 12 months old at inclusion with LDL-cholesterol level \< 1.9 g/L) and not taking cholesterol-lowering treatment.
  • Subjects who are affiliated or beneficiaries of a social security plan
  • Subject agreeing to participate in the study and having signed an informed consent

Exclusion Criteria

  • Protected person, as defined by articles L1121-5, L1121-6 and L1121-8 of the Public Health Code: pregnant or breastfeeding woman, person deprived of liberty by judicial decision, adult person unable to give consent.
  • Person who does not understand the French language

Outcomes

Primary Outcomes

Quantification of A2AR expression in PBMCs

Time Frame: 3 months after initiation of treatment

Comparison between hypercholesterolemic patients and healthy volunteers

Quantification of A2AR function in PBMC

Time Frame: Baseline

Comparison between hypercholesterolemic patients and healthy volunteers

Study Sites (1)

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