Lipids, Inflammation, and CV Risk in RA

Brigham and Women's Hospital74 enrolled

Overview

The objective of this study was to examine the relationship between inflammation, lipids, and cardiovascular risk in rheumatoid arthritis. The central hypothesis is that reducing inflammation will reduce cardiovascular risk as measured by coronary flow reserve. Additionally, we hypothesized that lipid levels may have a weaker correlation with CV risk compared to the general population.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatoid Arthritis Cardiovascular Disease

Interventions

CertolizumabDRUG

Eligibility

Sex: ALLMin age: 35 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * RA diagnosed by a rheumatologist * Fulfills the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Criteria for RA * Age\>35 * Active RA as defined by treating rheumatologist * Biologic DMARD naive Exclusion Criteria: * Patients on statin or PCSK9 inhibitor therapy * Corticosteroid therapy \>10mg prednisone or its equivalent as a maintenance treatment * Pregnancy * Unstable angina (chest pain) or shortness of breath * Severe valvular heart disease * Myocarditis * Pericarditis * Asthma with active wheezing * History of lymphoproliferative disease or melanoma (stage two or higher), active malignancy, or cancer treatment in the last 5 years * Active infectious disease (HIV, Tuberculosis, or Hepatitis B/C)

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Coronary Flow Reserve

The coronary flow reserve (CFR) is the ratio of myocardial blood flow at stress over myocardial blood flow at rest. This marker is ideally suited as the cardiac imaging biomarker for both a measure of coronary vasomotor function as well as surrogate CV outcome in RA.

Time frame: 24 weeks

Data from ClinicalTrials.gov

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