Clinical and Biochemical Assessment of the Course of Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 476
- 试验地点
- 2
- 主要终点
- mortality
研究概览
简要总结
one-centered, open, non-randomized, controlled clinical trial will focus on a comprehensive study of the clinical, functional and molecular biochemical characteristics of the natural course of COPD in combination with peripheral atherosclerosis
详细描述
Risk factors, chronic respiratory symptoms and respiratory function in the natural history of COPD will be monitored. In a group of patients with a comorbid course of COPD and atherosclerosis, systemic inflammation and its molecular mechanisms will be investigated. Also in this group, the role of non-coding miRNAs will be analyzed. The study also includes an analysis of the clinical and biochemical COPD phenotype with systemic inflammation and comorbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •A significant diagnosis of COPD, confirmed by spirometry criteria, typical clinical presentation.
- •A significant diagnosis of peripheral atherosclerosis
- •The high level of adherence to treatment
- •Signed informed agreement
排除标准
- •The presence of other chronic respiratory diseases in the patient, including bronchial asthma
- •Known oncological diseases of any localization
- •HIV infection and other immunodeficiency conditions
- •Inability to understand and comply with the requirements of the research protocol.
结局指标
主要结局
mortality
时间窗: 12 months
the number of deaths from cardiovascular causes
exacerbations
时间窗: 12 months
frequency of exacerbations of COPD (number of cases per year)
markers of inflammation
时间窗: 12 months
biochemical markers of inflammation (IL-6, pg/ml; IL-8,pg/ml;TNF,pg/ml)
lung function
时间窗: 12 months
progression of decreased lung function (FEV1%) according to spirometry
次要结局
未报告次要终点