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临床试验/NCT02468986
NCT02468986已完成不适用

Analysis of Endothelial Cells in Rheumatoid Arthritis

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2011年8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
56
试验地点
2
主要终点
Endothelial cell protein expression by immunofluorescence microscopy of endothelial nitric oxide synthase, nitrotyrosine, nuclear factor kappa B.

研究概览

简要总结

Heart disease is the major contributor of early death in rheumatoid arthritis (RA) and is not influenced by traditional risk factors. Blood vessel dysfunction has been associated with heart disease and complications such as heart attack. The vessel dysfunction is thought to be mediated in part to inflammation. RA patients have evidence of vessel dysfunction seen on ultrasound that improves after medications are given.

The purpose of this study is to evaluate patients with controlled or uncontrolled rheumatoid arthritis to determine if there is a difference in the protein expression in the cells that line the blood vessels compared to healthy people.

详细描述

The study will consist of a cross sectional analysis of venous endothelial cells in rheumatoid arthritis patients who have controlled or uncontrolled disease and healthy controls. We will collect venous endothelial cells by placing an IV in antegrade position in the forearm and a thin wire will be inserted to collect the cells from the inner lining of the vein. The cells will processed and stained for markers of endothelial function and oxidative stress including endothelial nitric oxide synthase (eNOS), phospho-eNOS, nuclear factor kappa B (NFκB), and nitrotyrosine using immunofluorescence technique. Flow mediated dilation (FMD) by ultrasound of the brachial artery on the contralateral arm will be used as an additional marker of endothelial function. A blood sample will be taken for analysis of inflammatory markers (sedimentation rate, C-reactive protein) and cytokine analysis (IL-1, IL-6, TNFa) by cytokine bead array and flow cytometry.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Rheumatoid arthritis:
  • Age 18-75 years
  • Rheumatoid arthritis defined by 1987 American College of Rheumatology criteria
  • Attending clinic at University of Texas Southwestern Aston Clinic for Rheumatology or Parkland Arthritis Clinic.
  • Healthy controls:
  • Age 18-75 years.

排除标准

  • Rheumatoid arthritis:
  • Insulin dependent diabetes
  • Cardiovascular or Cerebrovascular disease
  • Tobacco use in last 24 months
  • Uncontrolled blood pressure
  • Uncontrolled cholesterol
  • Pregnant or nursing
  • Prednisone greater than 10mg per day
  • Stable methotrexate dose for less than 4 weeks
  • Undergoing Infliximab infusions
  • Healthy controls:
  • Insulin dependent diabetes
  • Cardiovascular or Cerebrovascular disease
  • Tobacco use in last 24 months
  • Uncontrolled high blood pressure
  • Uncontrolled cholesterol
  • Pregnant or nursing

结局指标

主要结局

Endothelial cell protein expression by immunofluorescence microscopy of endothelial nitric oxide synthase, nitrotyrosine, nuclear factor kappa B.

时间窗: Cells are immediately processed following extraction and placed in -80 degree C freezer. Cells are then analyzed by immunofluorescence microscopy in batches of subjects. Patient is followed-up 24 hours after by phone.

Immunofluorescence microscopy of frozen endothelial cells will be processed in batches to reduce bias. Cells are assessed for individual protein expression at study entry. Repeated collection of cells will not been done.

次要结局

  • Serum cytokines analysis by cytometric bead array(Measured once upon enrollment into study. Patient is followed-up 24 hours after by phone.)
  • Flow mediated dilation assessed in the brachial artery by ultrasound(Measured once upon enrollment into study. Patient is followed-up 24 hours after by phone.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Blair Solow

ASSISTANT PROFESSOR

University of Texas Southwestern Medical Center

研究点 (2)

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