Low Density Lipoprotein Cholesterol (CLDL) as a Cardiovascular Disease Risk Factor in Rheumatoid Arthritis

NCT ID: NCT01105715

Last Updated: 2013-06-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-06-30

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.

Conditions

Rheumatoid Arthritis; Cardiovascular Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Rheumatoid Arthritis (RA) Case Subjects

• 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

No interventions assigned to this group

Control Subjects

• Age, sex, and 5-year age categories matched to cases
• No historical diagnosis of RA and other primary autoimmune or inflammatory disorders

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

UAMS 112170

Identifier Type: -

Identifier Source: org_study_id