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NCT Number: NCT02468986

Study of Venous Endothelial Cells in Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Parkland Memorial Hospital, Dallas, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Serum cytokines analysis by cytometric bead array

    Time frame: Measured once upon enrollment into study. Patient is followed-up 24 hours after by phone.

    Interleukin-1, Interleukin-6, Tumor Necrosis Factor -alpha

  2. Flow mediated dilation assessed in the brachial artery by ultrasound

    Time frame: Measured once upon enrollment into study. Patient is followed-up 24 hours after by phone.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • American Heart Association
  • Bristol-Myers Squibb

Registry information

Official study title

Analysis of Endothelial Cells in Rheumatoid Arthritis

Important dates

Study start
2011
Primary completion
2019
Study completion
2020
First posted
Jun 11, 2015
Registry last updated
Apr 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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