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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01105715
First received: April 15, 2010
Last updated: June 18, 2013
Last verified: June 2013

April 15, 2010
June 18, 2013
April 2010
June 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01105715 on ClinicalTrials.gov Archive Site
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Low Density Lipoprotein Cholesterol (CLDL) as a Cardiovascular Disease Risk Factor in Rheumatoid Arthritis
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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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

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.

  • Rheumatoid Arthritis
  • Cardiovascular Disease
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2013
June 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01105715
UAMS 112170
No
University of Arkansas
University of Arkansas
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University of Arkansas
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP