Atherosclerosis in Rheumatoid Arthritis

NCT ID: NCT00990730

Last Updated: 2012-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-06-30

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.

Conditions

Rheumatoid Arthritis; Endothelial Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

rheumatoid arthritis subjects

60 subjects with rheumatoid arthritis, defined by American College of Rheumatology Criteria, enrolled in the UCSF RA cohort

No interventions assigned to this group

healthy controls

20 matched controls without rheumatoid arthritis

No interventions assigned to this group

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
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Priscilla Hsue

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Priscilla Y Hsue, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Peter Ganz, MD

Role: STUDY_DIRECTOR

University of California, San Francisco

Locations

UCSF San Francisco General Hospital Vascular Research Center

San Francisco, California, United States

Countries

United States

Other Identifiers

F32HL097461-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SFGH GCRC 6128

Identifier Type: -

Identifier Source: secondary_id

H11397-34652-01

Identifier Type: -

Identifier Source: org_study_id