Lipids, Inflammation, and Cardiovascular Risk in Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- coronary flow reserve (CFR) measured by cardiac PET
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: certolizumab (Drug)
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.
干预措施: Stress myocardial perfusion PET (Radiation)
结局指标
主要结局
coronary flow reserve (CFR) measured by cardiac PET
时间窗: 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.
次要结局
未报告次要终点
研究者
Katherine P Liao
Associate Professor of Medicine
Brigham and Women's Hospital