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临床试验/NCT01105715
NCT01105715已完成不适用

cLDL as a Cardiovascular Disease Risk Factor in Rheumatoid Arthritis

University of Arkansas1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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