NCT00431405

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2007

Completed
Last Updated

February 5, 2007

Status Verified

February 1, 2007

First QC Date

February 1, 2007

Last Update Submit

February 1, 2007

Conditions

Keywords

rheumatoid arthritiscardiovascular diseasecoronary disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dallas VA Medical Center-Rheumatology

Dallas, Texas, 75216, United States

Location

Related 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. doi: 10.1002/art.1780370408.

    PMID: 8147925BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidCardiovascular DiseasesCoronary Disease

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesMyocardial IschemiaHeart DiseasesVascular Diseases

Study Officials

  • Salahuddin Kazi, MBBS

    Dallas VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
RETROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

February 1, 2007

First Posted

February 5, 2007

Study Start

August 1, 2006

Study Completion

January 1, 2007

Last Updated

February 5, 2007

Record last verified: 2007-02

Locations