An observational study in Rheumatoid Arthritis and Cardiovascular Disease, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-19.
Sponsored by University of Arkansas · Observational
The investigators hypothesize that cLDL levels are elevated in RA patients and represents an important mechanism for accelerated atherosclerosis leading to excess cardiovascular disease (CVD) in rheumatoid arthritis (RA) patients. The purpose of this study is to improve understanding of the reasons for increased cardiovascular diseases (such as heart attack and stroke) seen in patients with rheumatoid arthritis (RA, an arthritis that causes inflammation and destruction of joints). Specifically, the study plans to determine whether a particular type of change in proteins in LDL cholesterol ("bad cholesterol") known as carbamylation is an important risk factor for cardiovascular diseases in RA patients. The study will utilize a case-control study design. A total of 120 subjects (males and females between the ages of 18 and 80) may be enrolled in order to ensure that 100 subjects (50 RA case subjects and 50 age and sex matched controls) complete the study. Procedures will consist of a single visit for each subject during which a screening evaluation, an enrollment evaluation, and a single blood draw will be performed.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's planned enrollment of 100 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects will be recruited from the UAMS Rheumatology Clinic at the UAMS Outpatient Center, Little Rock, other UAMS outpatient clinics, or through advertisement at the UAMS campus and/or the community.
For Cases:
For Controls:
Exclusion Criteria:
For both cases and controls:
Renal failure (estimated GFR \< 60 ml/min) documented within 3 months of study enrollment (from either subject's self-report or review of available medical records)
* Fulfill the American College of Rheumatology (ACR) 1987 Classification Criteria for RA * Have currently active disease as assessed by Clinical Disease Activity Index (CDAI) score of \>10 * Have \> or = 3 swollen joints
* Age, sex, and 5-year age categories matched to cases * No historical diagnosis of RA and other primary autoimmune or inflammatory disorders
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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University of Arkansas