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

Rheumatoid Arthritis Clinical Trial

Official title:

Assessing Risk of Cardiovascular Events in RA Patients Using a Retrospective Cohort From the VARA Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00431405
• Other study ID #: COVARA
• Status: Active, not recruiting
• Phase: N/A
• First received: February 1, 2007
• Last updated: February 1, 2007
• Start date: August 2006
• Est. completion date: January 2007

Study information

• Verified date: February 2007
• Source: Dallas VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	Dallas VA Medical Center-Rheumatology	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Dallas VA Medical Center	Centocor, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation