Evaluation of a New Score Incorporating Endothelial Dysfunction for the Assessment of Coronary Heart Disease Risk in Patients With Rheumatoid Arthritis: a 3-year Prospective Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 试验地点
- 3
- 主要终点
- CHD events
研究概览
简要总结
To evaluate the contribution of the assessment of endothelial dysfunction (ED) in improving coronary hearth disease (CHD) risk stratification obtained by the Framingham risk score (FRS) in rheumatoid arthritis population (RA).
详细描述
ED, determined by peripheral arterial tonometry (PAT), will be evaluated at baseline in 3000 RA patients free of previous cardiovascular events. Incident CHD events during the 3-year planned follow-up will be registered. A measure of the incremental yield of ED will be obtained comparing 2-year Framingham risk score for CHD (FRS) and FRS plus ED differential prognostic performances by C-statics and risk reclassification analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RA as defined by American College of Rheumatology/European League Against Rheumatisms 2010 RA classification criteria
- •In the opinion of investigators, patients must be able to adhere to the study visit schedule and must be capable of giving informed consent
排除标准
- •Previous cardiovascular or cerebrovascular events (acute coronary syndrome, stable angina, stroke, interventional procedures, carotid endarterectomy, symptomatic peripheral artery ischemia)
- •Pathological ECG at rest
- •Sign or symptoms of autonomous nervous system dysfunction
- •Serious infections in the previous 6 months
- •Concomitant severe illness: overt hepatic insufficiency; End stage renal disease (Glomerular Filtration Rate <30 ml/h at Cockrofts-Gault formula); recent diagnosis of cancer
- •Pregnancy
- •Plans to leave target areas of each study site within three years
结局指标
主要结局
CHD events
时间窗: 3 year
The following events will be considered as incident CHD events: myocardial infarction, CHD death, resuscitated cardiac arrest, or definite or probable angina if followed by coronary revascularization.
次要结局
未报告次要终点
研究者
Gian Luca Erre, MD PhD
MD, PhD
Azienda Ospedaliero Universitaria di Sassari