Atherosclerosis in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990730
• Other study ID #: H11397-34652-01
• Secondary ID: F32HL097461-01SF
• Status: Completed
• Phase: N/A
• First received: October 2, 2009
• Last updated: January 23, 2012
• Start date: September 2009
• Est. completion date: June 2011

Study information

• Verified date: January 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Atherosclerosis
• Endothelial Dysfunction
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	UCSF San Francisco General Hospital Vascular Research Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	flow mediated vasodilation of the brachial artery, measured by ultrasound		1 day	No
Secondary	pulse wave velocity/arterial stiffness		day 1	No
Secondary	lipid metabolism		day 1	No
Secondary	pulse ampitude		1 day	No