Low Density Lipoprotein Cholesterol (CLDL) as a Cardiovascular Disease Risk Factor in Rheumatoid Arthritis

Study Overview
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Brief Summary
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The investigators hypothesize that cLDL levels are elevated in RA patients and represents an important mechanism for accelerated atherosclerosis leading to excess cardiovascular disease (CVD) in rheumatoid arthritis (RA) patients. The purpose of this study is to improve understanding of the reasons for increased cardiovascular diseases (such as heart attack and stroke) seen in patients with rheumatoid arthritis (RA, an arthritis that causes inflammation and destruction of joints). Specifically, the study plans to determine whether a particular type of change in proteins in LDL cholesterol (bad cholesterol) known as carbamylation is an important risk factor for cardiovascular diseases in RA patients. The study will utilize a case-control study design. A total of 120 subjects (males and females between the ages of 18 and 80) may be enrolled in order to ensure that 100 subjects (50 RA case subjects and 50 age and sex matched controls) complete the study. Procedures will consist of a single visit for each subject during which a screening evaluation, an enrollment evaluation, and a single blood draw will be performed.

Official Title
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cLDL as a Cardiovascular Disease Risk Factor in Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis, Cardiovascular Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For Cases: Fulfill the American College of Rheumatology (ACR) 1987 Classification Criteria for RA Have currently active disease as assessed by Clinical Disease Activity Index (CDAI)score (a validated composite RA activity index) of > 10 Have ≥ 3 swollen joints For Controls: Control subjects will be age, sex, and 5-year age categories matched to cases No historical diagnosis of RA and other primary autoimmune or inflammatory disorders Exclusion Criteria: For both cases and controls: Renal failure (estimated GFR < 60 ml/min) documented within 3 months of study enrollment (from either subject's self-report or review of available medical records) Known clinical history of CVD Current cancer (other than skin) Current or recent (within past 2 weeks) infection Individuals taking lipid-lowering medications Any other condition the PI staff feels will jeopardize the health and welfare of the participants Rheumatoid vasculitis (for cases only)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rheumatoid Arthritis (RA) Case Subjects<br>Fulfill the American College of Rheumatology (ACR) 1987 Classification Criteria for RA Have currently active disease as assessed by Clinical Disease Activity Index (CDAI) score of >10 Have > or = 3 swollen joints | |
| Control Subjects<br>Age, sex, and 5-year age categories matched to cases No historical diagnosis of RA and other primary autoimmune or inflammatory disorders | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, cLDL, Cardiovascular disease