Atherosclerosis in Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Priscilla Hsue, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00990730
First received: October 2, 2009
Last updated: January 23, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to investigate the link between rheumatoid arthritis and cardiovascular disease by studying inflammation, joint disease, cholesterol abnormalities, and endothelial function.


Condition
Rheumatoid Arthritis
Endothelial Dysfunction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Atherosclerosis in Rheumatoid Arthritis: Role of Inflammation, Lipoproteins, and Endothelial Dysfunction

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • flow mediated vasodilation of the brachial artery, measured by ultrasound [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pulse wave velocity/arterial stiffness [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • lipid metabolism [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • pulse ampitude [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum, plasma


Enrollment: 80
Study Start Date: September 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
rheumatoid arthritis subjects
60 subjects with rheumatoid arthritis, defined by American College of Rheumatology Criteria, enrolled in the UCSF RA cohort
healthy controls
20 matched controls without rheumatoid arthritis

Detailed Description:

In the general population, individuals with elevated inflammatory markers (e.g. C-reactive protein, CRP) have increased cardiovascular disease. Patients with RA have chronic elevations in CRP and other inflammatory markers that are usually higher than the levels associated with increased cardiovascular risk in the general population. Indeed, RA patients have accelerated disease of their blood vessels, and increased cardiovascular death not explained by traditional cardiac risk factors but associated with chronic inflammation. However, the mechanisms by which inflammation leads to cardiovascular disease are not well characterized in RA. Moreover, current treatment strategies of RA largely target joint symptoms rather than inflammation, potentially leaving patients at increased risk for cardiovascular disease. Studies of markers that increase the risk of heart disease in the full spectrum of RA are missing. We hypothesize that inflammatory markers will be more strongly associated with abnormalities in blood vessels in RA patients than any clinical measure of disease activity. This hypothesis will be tested with a cross-sectional study of patients in the UCSF RA cohort. Aim 1 will characterize abnormal blood vessel changes across the spectrum of RA disease activity, specifically measuring ultrasound of the upper arm artery, markers of oxidative stress, and abnormalities in cholesterol proteins. Aim 2 will identify factors associated with these changes across the spectrum of RA disease activity, specifically focusing on the association between inflammatory markers, cholesterol, and blood vessel abnormalities.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

RA subjects are from the UCSF RA cohort based at San Francisco General Hospital and UCSF Medical Center. Controls will be selected from primary care clinics from these hospitals

Criteria

Inclusion Criteria:

  • Diagnosis of RA by ACR criteria
  • Age 18-80
  • Enrolled in UCSF RA cohort already

Exclusion Criteria:

  • Diabetes (on meds or in medical history)
  • Pregnant or Lactating
  • Renal failure (Creatinine > 2mg/dL or on dialysis)
  • History of MI or CAD
  • History of ischemic CVA
  • Symptomatic PVD
  • Current uncontrolled hypertension (blood pressure > 160/100mmHg)
  • Daily prednisone > 10mg daily
  • Current smoker
  • New BP med within 3 months
  • New statin within 3 months
  • Change in RA meds: new or increase in prednisone within 1 month, new TNF inhibitor within 2 months, titration of methotrexate, leflunomide or sulfasalazine within 3 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990730

Locations
United States, California
UCSF San Francisco General Hospital Vascular Research Center
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Priscilla Y Hsue, MD University of California, San Francisco
Study Director: Peter Ganz, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Priscilla Hsue, Principle Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00990730     History of Changes
Other Study ID Numbers: H11397-34652-01, F32 HL097461-01, SFGH GCRC 6128
Study First Received: October 2, 2009
Last Updated: January 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
rheumatoid arthritis
endothelial dysfunction
lipoproteins
inflammation
oxidative stress
arterial stiffness

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Atherosclerosis
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014