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Study of Venous Endothelial Cells in Rheumatoid Arthritis

Analysis of Endothelial Cells in Rheumatoid Arthritis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02468986
Enrollment
56
Registered
2015-06-11
Start date
2011-08-31
Completion date
2020-12-31
Last updated
2021-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

American Heart Association
CollaboratorOTHER
Bristol-Myers Squibb
CollaboratorINDUSTRY
University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

MeasureTime frameDescription
Serum cytokines analysis by cytometric bead arrayMeasured once upon enrollment into study. Patient is followed-up 24 hours after by phone.Interleukin-1, Interleukin-6, Tumor Necrosis Factor -alpha
Flow mediated dilation assessed in the brachial artery by ultrasoundMeasured once upon enrollment into study. Patient is followed-up 24 hours after by phone.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026