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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Dallas VA Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by:
Dallas VA Medical Center
ClinicalTrials.gov Identifier:
NCT00431405
First received: February 1, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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
Rheumatoid Arthritis
Cardiovascular Disease
Coronary Disease

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Assessing Risk of Cardiovascular Events in RA Patients Using a Retrospective Cohort From the VARA Registry

Resource links provided by NLM:


Further study details as provided by Dallas VA Medical Center:

Estimated Enrollment: 450
Study Start Date: August 2006
Estimated Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00431405     History of Changes
Other Study ID Numbers: COVARA
Study First Received: February 1, 2007
Last Updated: February 1, 2007
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on August 28, 2014