Skip to main content
OpenTrials
Completed

NCT Number: NCT00990730

Atherosclerosis in Rheumatoid Arthritis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF San Francisco General Hospital Vascular Research Center

San Francisco, California, 94110, United States

About this study

In the general population, individuals with elevated inflammatory markers (e.g. C-reactive protein, CRP) have increased cardiovascular disease. Patients with RA have chronic elevations in CRP and other inflammatory markers that are usually higher than the levels associated with increased cardiovascular risk in the general population. Indeed, RA patients have accelerated disease of their blood vessels, and increased cardiovascular death not explained by traditional cardiac risk factors but associated with chronic inflammation. However, the mechanisms by which inflammation leads to cardiovascular disease are not well characterized in RA. Moreover, current treatment strategies of RA largely target joint symptoms rather than inflammation, potentially leaving patients at increased risk for cardiovascular disease. Studies of markers that increase the risk of heart disease in the full spectrum of RA are missing. We hypothesize that inflammatory markers will be more strongly associated with abnormalities in blood vessels in RA patients than any clinical measure of disease activity. This hypothesis will be tested with a cross-sectional study of patients in the UCSF RA cohort. Aim 1 will characterize abnormal blood vessel changes across the spectrum of RA disease activity, specifically measuring ultrasound of the upper arm artery, markers of oxidative stress, and abnormalities in cholesterol proteins. Aim 2 will identify factors associated with these changes across the spectrum of RA disease activity, specifically focusing on the association between inflammatory markers, cholesterol, and blood vessel abnormalities.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. flow mediated vasodilation of the brachial artery, measured by ultrasound

    Time frame: 1 day

Secondary outcomes

  1. pulse wave velocity/arterial stiffness

    Time frame: day 1

  2. lipid metabolism

    Time frame: day 1

  3. pulse ampitude

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

Atherosclerosis in Rheumatoid Arthritis: Role of Inflammation, Lipoproteins, and Endothelial Dysfunction

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 7, 2009
Registry last updated
Jan 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.