Clinical trial NCT01105715: Low Density Lipoprotein Cholesterol (CLDL) as a Cardiovascular Disease Risk Factor in Rheumatoid Arthritis
Official title: cLDL as a Cardiovascular Disease Risk Factor in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Cardiovascular Disease
Keywords: Rheumatoid Arthritis
cLDL
Cardiovascular disease
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2010-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

For Cases:

* 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 (a validated composite RA activity index) of \> 10
* Have ≥ 3 swollen joints

For Controls:

* Control subjects will be age, sex, and 5-year age categories matched to cases
* No historical diagnosis of RA and other primary autoimmune or inflammatory disorders

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)

* Known clinical history of CVD
* Current cancer (other than skin)
* Current or recent (within past 2 weeks) infection
* Individuals taking lipid-lowering medications
* Any other condition the PI staff feels will jeopardize the health and welfare of the participants
* Rheumatoid vasculitis (for cases only)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
References: