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

NCT01105715 | Completed

• 1 other identifier: UAMS 112170
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Rheumatoid Arthritis; cLDL; Cardiovascular disease

Study Arms (2)

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

Control Subjects

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

If a subject consents, any blood samples remaining after the tests planned for this study will be stored indefinitely for potential future new studies. Any future new studies using these blood samples will require prior approval by the UAMS Institutional Review Board (IRB). A subject may request destruction of the stored samples at any time.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 16, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

US (1)