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

Sponsor

University of Arkansas (Other)

Overall Status

Completed

CT.gov ID

NCT01105715

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Cardiovascular Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

cLDL as a Cardiovascular Disease Risk Factor in Rheumatoid Arthritis

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)