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NCT01180361Completed

Atherosclerosis in Rheumatoid Arthritis and Lupus: Restoring Cholesterol Balance

Atherosclerosis in RA and Lupus: Restoring Cholesterol Balance

Source: ClinicalTrials.gov · Last updated 30 Oct 2025

Brief summary (registry, in English)

Hypothesis: SLE and RA increase risk of myocardial infarction (MI, heart attack). Immune reactants in the circulation of SLE patients downregulate cholesterol efflux proteins 27-hydroxylase and ABCA1 and upregulate scavenger receptor CD36, thus encouraging cholesterol accumulation. Adenosine A2A receptor agonist or statin treatment of cells exposed to SLE plasma (or immune complexes or cytokine-enriched plasma fractions from SLE patients) may ameliorate inflammatory properties of their plasma, lessening its atherogenic potency. Rationale: SLE and RA plasma contain components not present in significant levels in normal plasma that could, individually or acting together, affect 27-hydroxylase, ABCA1 and CD36 expression. Candidate components include autoantibodies, immune complexes, and various cytokines. Statins reduce major cardiovascular events and death. Modulation of adenosine signaling participates in regulation of 27-hydroxylase and ABCA1. As a potential preventative and therapeutic approach to atherosclerotic cardiovascular disease, the investigators evaluate the effect of A2A receptor agonists and statins on atherogenic parameters in SLE and RA plasma. Experimental Plan: Quantitate 27-hydroxylase and several other proteins involved in cellular cholesterol uptake and excretion in THP-1 monocytes/macrophages and HAEC after exposure to plasma and plasma components from SLE patients (and controls) ± lipid loading with acetylated LDL with/without addition of A2AR agonist, statin, or both. Determine relative impact of immune complexes and cytokines on expression of proteins involved in cholesterol flux. Determine levels of proteins involved in cellular cholesterol influx/efflux in peripheral blood mononuclear cells isolated from RA, SLE and psoriatic arthritis patients and normal controls at baseline, then following incubation in culture media alone or with statin, adenosine A2A agonist or both statin + A2AR agonist.

Status (registry)
Completed
Study type
Observational
Enrollment
176 (actual)
First submitted
10 Aug 2010
Start date
Sept 2008
Primary completion date
20 Jun 2025
Lead sponsor
NYU Langone Health
NCT number
NCT01180361

What you commit to

  • Study type: Observational
  • Participants enrolled: 176
  • From Sept 2008 to the primary completion date, 20 Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • No methotrexate or statin therapy in prior 3 months.
  • Not on biological therapies.

Who the study is looking for

  • Males and females age 18-65

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
NYU Langone Hospital - Long Island
Coordinator of this site? Confirm its status
MineolaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.