Clinical trial NCT00990730: Atherosclerosis in Rheumatoid Arthritis
Official title: Atherosclerosis in Rheumatoid Arthritis: Role of Inflammation, Lipoproteins, and Endothelial Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Endothelial Dysfunction
Keywords: rheumatoid arthritis
endothelial dysfunction
lipoproteins
inflammation
oxidative stress
arterial stiffness
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-10-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

Brief summary: 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.

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 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.

Primary outcomes:
measure: flow mediated vasodilation of the brachial artery, measured by ultrasound
timeFrame: 1 day
Secondary outcomes:
measure: pulse wave velocity/arterial stiffness
timeFrame: day 1
measure: lipid metabolism
timeFrame: day 1
measure: pulse ampitude
timeFrame: 1 day
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF San Francisco General Hospital Vascular Research Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Priscilla Y Hsue, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Peter Ganz, MD
role: STUDY_DIRECTOR
References: