Overview

This trial is active, not recruiting.

Conditions rheumatoid arthritis, cardiovascular disease, coronary disease
Sponsor Dallas VA Medical Center
Collaborator Centocor, Inc.
Start date August 2006
End date January 2007
Trial size 450 participants
Trial identifier NCT00431405, COVARA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model defined population
Time perspective longitudinal

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Assessing Risk of Cardiovascular Events in RA Patients Using a Retrospective Cohort From the VARA Registry
Principal investigator Salahuddin Kazi, MBBS
Trial information was received from ClinicalTrials.gov and was last updated in February 2007.
Information provided to ClinicalTrials.gov by Dallas VA Medical Center.