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NCT01180361 · ClinicalTrials.gov registry record
Atherosclerosis in Rheumatoid Arthritis and Lupus: Restoring Cholesterol Balance
A clinical trial, sponsored by NYU Langone Health.
- Completed
- Registry status
- 176
- Enrollment target
NCT01180361: Completed study, sponsored by NYU Langone Health.
NCT01180361 is a clinical trial that has completed, run by NYU Langone Health. The registered enrollment target is 176 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01180361 has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- 176 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The activated proinflammatory state of monocytes in RA and SLE subjects constitutes a novel parameter of risk associated with this disorder, related to altered expression of cholesterol transport genes. 27-hydroxylase level may be diminished by the plasma of patents with autoimmune rheumatic disorders.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2008-09 |
| Est. Completion | 2025-06-20 |
What the finished NCT01180361 record still lists
NCT01180361 is an observational study that tracks outcomes without assigning an intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01180361 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01180361 about?
NCT01180361 is a clinical study titled "Atherosclerosis in Rheumatoid Arthritis and Lupus: Restoring Cholesterol Balance". 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 rec...
What is the current status of trial NCT01180361?
This trial is currently completed. The enrollment target is 176 participants. The study started on 2008-09. Estimated completion is 2025-06-20.
Who is sponsoring clinical trial NCT01180361?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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