Cardiovascular Outcomes in the VA's Rheumatoid Arthritis(VARA) Population

NCT ID: NCT00431405

Last Updated: 2007-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2007-01-31

Brief Summary

Rheumatoid arthritis (RA) is a symmetric, peripheral polyarthritis of uncertain etiology that can lead to joint deformity and destruction. However, the effects of RA are not confined simply to joint involvement. Virtually every organ system can be affected by RA if left untreated. Of particular note is RA's affect on the cardiovascular system. RA patients have a reduced lifespan compared to the general population primarily due to an increased cardiovascular disease burden (1). Recently, RA has been linked to the development of preclinical atherosclerosis in the carotid arteries as measured by ultrasonography (2). Women with RA have also been shown to have an increased incidence of nonfatal myocardial infarctions (3). Despite these studies showing the effects of RA on the cardiovascular disease burden of those who are afflicted, no study to date has compared the number of cardiovascular events in a large RA patient population to a risk factor and age matched control group. Consequently it is the goal of this study to determine whether the cardiovascular event ratio in an RA patient cohort exceeds an age and risk factor matched cohort of non-RA patients. This study will also attempt to ascertain whether specific cardiovascular risk factors contribute to the cardiovascular morbidity and mortality associated with RA and if any standard cardiovascular medicines disproportionately contribute to patient outcome.

Hypothesis: Given the increased cardiovascular disease burden associated with RA patients they are likely to suffer from a statistically significant increased risk of cardiovascular events when compared to an age and risk factor matched cohort.

Conditions

Rheumatoid Arthritis; Cardiovascular Disease; Coronary Disease

Study Design

• Observational Model Type: DEFINED_POPULATION
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patient included in the VA Rheumatoid Arthritis database previously, who by definition will meet criteria for RA.
• Control subjects will not carry the diagnosis of RA.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: collaborator

Dallas VA Medical Center

FED

Sponsor Role: lead

Principal Investigators

Salahuddin Kazi, MBBS

Role: PRINCIPAL_INVESTIGATOR

Dallas VA Medical Center

Locations

Dallas VA Medical Center-Rheumatology

Dallas, Texas, United States

Countries

United States

References

Wolfe F, Mitchell DM, Sibley JT, Fries JF, Bloch DA, Williams CA, Spitz PW, Haga M, Kleinheksel SM, Cathey MA. The mortality of rheumatoid arthritis. Arthritis Rheum. 1994 Apr;37(4):481-94. doi: 10.1002/art.1780370408.

Reference Type: BACKGROUND

PMID: 8147925 (View on PubMed)

Other Identifiers

COVARA

Identifier Type: -

Identifier Source: org_study_id