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Study of Venous Endothelial Cells in Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468986
Recruitment Status : Active, not recruiting
First Posted : June 11, 2015
Last Update Posted : April 13, 2020
Sponsor:
Collaborators:
American Heart Association
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.


Condition or disease
Rheumatoid Arthritis

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.

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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Analysis of Endothelial Cells in Rheumatoid Arthritis
Actual Study Start Date : August 2011
Actual Primary Completion Date : August 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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.

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.
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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. ]

Biospecimen Retention:   Samples Without DNA
Serum collected by serum separator tube. Will be processed and frozen at -80degrees.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Rheumatoid arthritis patients will be selected from arthritis clinics associated with UT Southwestern Medical Center and Parkland Memorial Hospital. Healthy controls will be collected from primary care clinics who refer to these specialty clinics.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468986


Locations
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United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
University of Texas Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
American Heart Association
Bristol-Myers Squibb
Investigators
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Principal Investigator: Elizabeth B Solow, MD University of Texas
Principal Investigator: David Karp, MD, PhD University of Texas
Publications:

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02468986    
Other Study ID Numbers: STU 012011-034
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Keywords provided by University of Texas Southwestern Medical Center:
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases