Study of Venous Endothelial Cells in Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2020-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Uncontrolled Rheumatoid Arthritis

18-75 years old; Rheumatoid arthritis, defined by 1987 American College Rheumatology criteria; Attending clinic at Aston Center for Rheumatology or Parkland Rheumatology Clinic; Uncontrolled: Patients will be labeled as uncontrolled RA if Disease Activity Score (DAS) score is \>3.2 and C-reactive protein (mg/dL) elevated above normal range.

Excluding: Insulin dependent diabetes; Cardiovascular or Cerebrovascular disease (history of myocardial infarction, stroke, peripheral vascular disease); Tobacco use in the past 24 months; Uncontrolled hypertension (BP \> 150/90) in the past 3 months; Uncontrolled hyperlipidemia (LDL\>160) in the past 6 months; Pregnant or nursing.

No interventions assigned to this group

Controlled Rheumatoid Arthritis

18-75 years old; Rheumatoid arthritis, defined by 1987 American College Rheumatology criteria; Attending clinic at Aston Center for Rheumatology or Parkland Rheumatology Clinic; Controlled: Disease activity score (DAS) \<3.2, normal C-reactive protein. Excluding: Insulin dependent diabetes; Cardiovascular or Cerebrovascular disease (history of myocardial infarction, stroke, peripheral vascular disease); Tobacco use in the past 24 months; Uncontrolled hypertension (BP \> 150/90) in the past 3 months; Uncontrolled hyperlipidemia (LDL\>160) in the past 6 months; Pregnant or nursing.

No interventions assigned to this group

Healthy Controls

18-75 years old. Excluding: Insulin dependent diabetes; Cardiovascular or Cerebrovascular disease (history of myocardial infarction, stroke, peripheral vascular disease); Tobacco use in the past 24 months; Uncontrolled hypertension (BP \> 150/90) in the past 3 months; Uncontrolled hyperlipidemia (LDL\>160) in the past 6 months; Pregnant or nursing.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes