Atherosclerosis in Rheumatoid Arthritis

This study is currently recruiting participants.
Verified by University of California, San Francisco, October 2009
First Received: October 2, 2009 Last Updated: October 5, 2009

University of California, San Francisco
National Institutes of Health (NIH)
Information provided by:
University of California, San Francisco Identifier:

The purpose of this study is to investigate the link between rheumatoid arthritis and cardiovascular disease by studying inflammation, joint disease, cholesterol abnormalities, and endothelial function.

Rheumatoid Arthritis Endothelial Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Atherosclerosis in Rheumatoid Arthritis: Role of Inflammation, Lipoproteins, and Endothelial Dysfunction

Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:

  • flow mediated vasodilation of the brachial artery, measured by ultrasound [ Time Frame: at day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • pulse wave amplitude [ Time Frame: at day 1 ] [ Designated as safety issue: No ]
  • pulse wave velocity/arterial stiffness [ Time Frame: at day 1 ] [ Designated as safety issue: No ]
  • lipid metabolism [ Time Frame: at day 1 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA
serum, plasma

Estimated Enrollment: 80
Study Start Date: September 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

rheumatoid arthritis subjects
60 subjects with rheumatoid arthritis, defined by American College of Rheumatology
Criteria, enrolled in the UCSF RA cohort
healthy controls
20 matched controls without rheumatoid arthritis

Ages Eligible for Study: 18 Years to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Sampling Method: Probability Sample

Study Population
RA subjects are from the UCSF RA cohort based at San Francisco General Hospital and UCSF Medical Center. Controls will be selected from primary care clinics from these hospitals

Inclusion Criteria:

  • Diagnosis of RA by ACR criteria
  • Age 18-80
  • Enrolled in UCSF RA cohort already

Exclusion Criteria:

  • Diabetes (on meds or in medical history)
  • Pregnant or Lactating
  • Renal failure (Creatinine > 2mg/dL or on dialysis)
  • History of MI or CAD
  • History of ischemic CVA
  • Symptomatic PVD
  • Current uncontrolled hypertension (blood pressure > 160/100mmHg)
  • Daily prednisone > 10mg daily
  • Current smoker
  • New BP med within 3 months
  • New statin within 3 months
  • Change in RA meds: new or increase in prednisone within 1 month, new TNF inhibitor within 2 months, titration of methotrexate, leflunomide or sulfasalazine within 3 months.
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