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

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ClinicalTrials.gov Identifier: NCT00431405
Recruitment Status : Unknown
Verified February 2007 by Dallas VA Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : February 5, 2007
Last Update Posted : February 5, 2007
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by:
Dallas VA Medical Center

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.


Condition or disease
Rheumatoid Arthritis Cardiovascular Disease Coronary Disease

Study Type : Observational
Enrollment : 450 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective
Official Title: Assessing Risk of Cardiovascular Events in RA Patients Using a Retrospective Cohort From the VARA Registry
Study Start Date : August 2006
Study Completion Date : January 2007

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U.S. FDA Resources





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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00431405


Locations
United States, Texas
Dallas VA Medical Center-Rheumatology
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Dallas VA Medical Center
Centocor, Inc.
Investigators
Principal Investigator: Salahuddin Kazi, MBBS Dallas VA Medical Center

Publications:
ClinicalTrials.gov Identifier: NCT00431405     History of Changes
Other Study ID Numbers: COVARA
First Posted: February 5, 2007    Key Record Dates
Last Update Posted: February 5, 2007
Last Verified: February 2007

Keywords provided by Dallas VA Medical Center:
rheumatoid arthritis
cardiovascular disease
coronary disease

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases