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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00431405
Other study ID # COVARA
Secondary ID
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
Est. primary completion date
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


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

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