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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01105715
First received: April 15, 2010
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

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
Rheumatoid Arthritis
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: cLDL as a Cardiovascular Disease Risk Factor in Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Arkansas:

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.


Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105715

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01105715     History of Changes
Other Study ID Numbers: UAMS 112170
Study First Received: April 15, 2010
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
Rheumatoid Arthritis
cLDL
Cardiovascular disease

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Cardiovascular Diseases
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013