Inflammation and the Heart
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Left Ventricular Mass Indexed to BSA, g/m^2
研究概览
简要总结
Studies have shown that people with rheumatoid arthritis (RA) have a higher rate of heart disease than people that do not have RA. we believe this is caused by the inflammation produced by RA.
详细描述
Aim 1: We want to study people with RA to see if we can detect very early changes in their heart muscle and compare these results to people who do not have RA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Individuals specialized in cMRI performed the analyses and were blinded to disease status of participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Age >= 18
- •RA only: meet American College of Rheumatology(ACR)criteria for Diagnosis of RA
- •Controls only: no evidence of RA or other inflammatory disease
排除标准
- •Previous or current heart failure or ischemic cardiovascular disease (eg stroke, myocardial infarction, angina, CABG, stent).
- •Atrial fibrillation.
- •Known structural or functional cardiac abnormality, including pulmonary htn.
- •Glomerular filtration rate < 60 ml/min.
- •Pregnancy or breastfeeding.
- •Unable to perform MRI (claustrophobia, unable to fit in magnet,pacemaker,defibrillator or non-MR safe implant).
- •Hypersensitivity to gadolinium.
研究组 & 干预措施
rheumatoid arthritis patients
People who have rheumatoid arthritis underwent cMRI
干预措施: cardiac Magnetic Resonance imaging (Other)
controls
people who do not have RA or other inflammatory disease underwent cMRI
干预措施: cardiac Magnetic Resonance imaging (Other)
结局指标
主要结局
Left Ventricular Mass Indexed to BSA, g/m^2
时间窗: one scan, cross sectional comparison
Left Ventricular Mass (LVM) is known to increase in proportion to overall body size and differs by gender. To assess an individual's risk for a cardiovascular event based on LVM,an adjustment for the patient's body size should be done. LVM in grams was divided by body surface area in meters squared, to adjust for body size. Body surface area was calculated by square root (height (cm) X weight (kg)/3600).
次要结局
- Left Atrium Size, mm(one scan, cross sectional comparison)
研究者
C. Michael Stein
Dan May Professor of Medicine, Professor of Pharmacology, Assistant Director of the Division of Clinical Pharmacology
Vanderbilt University