Evaluation and Management of Cardiovascular Risk Factors in Inflammatory and Acquired Dysimmune Diseases (CARMIN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 主要终点
- The occurrence of any cardiovascular event (will be recorded from the patient files and/or phone calls to patient")
研究概览
简要总结
The hypothesis is that chronic inflammatory dysimmune state promotes the development of cardiovascular complications. The biological assumption is based on the fact that chronic inflammation promotes lesions of the vessel wall (endothelial alterations, calcification, atherosclerosis). The clinical aim is to allow to identify high-risk patients and to act in prevention.
The project CARMIN involves the assessment of cardiovascular risk factors, their management, and their influence on cardiovascular prognosis in patients with autoimmune diseases and immunodeficiencies acquired. It is based on the creation and monitoring of a cohort of patients with different types of dysimmune disorders: systemic lupus erythematosus, rheumatoid arthritis, psoriasis, scleroderma, systemic vasculitis ANCA, kidney transplants, and hematopoietic stem cells transplants.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients followed in the various services of medical specialties pole of the Edouard Herriot hospital
- •The diagnosis of the pathology selected for this study based on a clear clinical and biological evaluation supported by criteria specific to each pathology and compatible with international standards.
- •Date of diagnosis should not be less than 5 years (+/- 1 year), except for scleroderma patients where it has been extended to 10 years.
- •For kidney transplant patients the investigators take into account only patients with a maximum of 2 years of dialysis before graft.
排除标准
- •Diabetic patients
- •HIV seropositive
- •Patients with multiple pathologies
结局指标
主要结局
The occurrence of any cardiovascular event (will be recorded from the patient files and/or phone calls to patient")
时间窗: 2 years
The cardiovascular events : cardiovascular death, myocardial infarction, stroke, peripheral arterial disease, ischemic manifestations in other territories, heart failure, arrhythmia, deep vein thrombosis or pulmonary embolism.
次要结局
未报告次要终点