Lipids, Inflammation, and Cardiovascular Risk in Rheumatoid Arthritis
Overview
- Phase
- Not Applicable
- Intervention
- certolizumab
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- coronary flow reserve (CFR) measured by cardiac PET
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
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.
Investigators
Katherine P Liao
Associate Professor of Medicine
Brigham and Women's Hospital
Eligibility Criteria
Inclusion Criteria
- •RA diagnosed by a rheumatologist
- •Fulfills the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Criteria for RA
- •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)
Arms & Interventions
Tumor necrosis factor inhibitor
Subjects who are about to start on a tumor necrosis factor inhibitor (TNFi) as part of usual care will be recruited. They will have measurements including routine lipids, advanced lipoproteins, and coronary flow reserve (CFR) before and after their TNFi.
Intervention: certolizumab
Tumor necrosis factor inhibitor
Subjects who are about to start on a tumor necrosis factor inhibitor (TNFi) as part of usual care will be recruited. They will have measurements including routine lipids, advanced lipoproteins, and coronary flow reserve (CFR) before and after their TNFi.
Intervention: Stress myocardial perfusion PET
Outcomes
Primary Outcomes
coronary flow reserve (CFR) measured by cardiac PET
Time Frame: 24 weeks
The investigators will compare the CFR of subjects before baseline with their CFR after 24 weeks on TNFi. Each subject serves as their own control.