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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Cardiovascular Disease Cardiovascular Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

cLDL as a Cardiovascular Disease Risk Factor in Rheumatoid Arthritis

Acronym: cLDL in RA

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Apr 16, 2010
Registry last updated: Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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