Role of A2A Receptor in Hypercholesterolemic Patients

NCT05017649 | Recruiting

• 2 other identifiers: 2021-07ID-RCB
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Keywords

hypercholesterolemia; adenosine receptor; PBMC

Outcome Measures

Primary Outcomes (4)

• Quantification of A2AR expression in PBMCs

  Comparison between hypercholesterolemic patients and healthy volunteers

  Baseline

• Quantification of A2AR expression in PBMCs

  Comparison between hypercholesterolemic patients and healthy volunteers

  3 months after initiation of treatment

• Quantification of A2AR function in PBMC

  Comparison between hypercholesterolemic patients and healthy volunteers

  3 months after initiation of treatment

• Quantification of A2AR function in PBMC

  Comparison between hypercholesterolemic patients and healthy volunteers

  Baseline

Study Arms (3)

Healthy volunteers

OTHER

volunteers showing no hypercholesterolemia

Biological: Blood sample

Patients with untreated hypercholesterolemia at the time of inclusion

EXPERIMENTAL

patients presenting hypercholesterolemia with no treatment at the time of inclusion

Biological: Blood sample

Patients with treated hypercholesterolemia at the time of inclusion

EXPERIMENTAL

patients presenting hypercholesterolemia and treated at the time of inclusion

Biological: Blood sample

Interventions

Blood sample BIOLOGICAL

Blood sampling.

Healthy volunteers; Patients with treated hypercholesterolemia at the time of inclusion; Patients with untreated hypercholesterolemia at the time of inclusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 18-80 years
• For the group of hypercholesterolemic patients :
• For the healthy group :
• ● No cholesterol-modifying therapy.
• Subjects who are affiliated or beneficiaries of a social security plan
• Subject agreeing to participate in the study and having signed an informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Service Endocrinologie

Marseille, 13005, France

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• François CREMIEUX

  AP-HM

  STUDY DIRECTOR

Central Study Contacts

René Valero

CONTACT

0491387577; rene.valero@ap-hm.fr

René Valéro

CONTACT

0491387577; rene.valero@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 24, 2021
• Study Start: September 20, 2021
• Primary Completion: March 19, 2026
• Study Completion (Estimated): June 19, 2026
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)