Atherosclerosis in Rheumatoid Arthritis

Completed

• Conditions: Endothelial Dysfunction; Rheumatoid Arthritis

• Registration Number: NCT00990730
• Lead Sponsor: University of California, San Francisco

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-05
• Study First Posted: 2009-10-07
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-23
• Last Update Posted: 2012-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
flow mediated vasodilation of the brachial artery, measured by ultrasound	1 day

Secondary Outcome Measures

Name	Time	Method
lipid metabolism	day 1
pulse wave velocity/arterial stiffness	day 1
pulse ampitude	1 day

Trial Locations

Locations (1)

UCSF San Francisco General Hospital Vascular Research Center; 🇺🇸 San Francisco, California, United States