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Clinical Trials/NCT00990730
NCT00990730
Completed
N/A

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

University of California, San Francisco1 site in 1 country80 target enrollmentSeptember 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rheumatoid Arthritis
Sponsor
University of California, San Francisco
Enrollment
80
Locations
1
Primary Endpoint
flow mediated vasodilation of the brachial artery, measured by ultrasound
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
June 2011
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Priscilla Hsue

Principle Investigator

University of California, San Francisco

Eligibility Criteria

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

Outcomes

Primary Outcomes

flow mediated vasodilation of the brachial artery, measured by ultrasound

Time Frame: 1 day

Secondary Outcomes

  • lipid metabolism(day 1)
  • pulse wave velocity/arterial stiffness(day 1)
  • pulse ampitude(1 day)

Study Sites (1)

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