Study of Venous Endothelial Cells in Rheumatoid Arthritis

The University of Texas System (UT)

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02468986

STU 012011-034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

56 participants in 3 patient groups

Uncontrolled Rheumatoid Arthritis

Description:

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.

Controlled Rheumatoid Arthritis

Description:

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.

Healthy Controls

Description:

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.