跳至主要内容
临床试验/NCT02888886
NCT02888886已完成不适用

Role of Systemic Inflammation in Increase of Cardio-vascular Risk in Chronic Obstructive Pulmonary Disease

Central Hospital, Nancy, France0 个研究点目标入组 89 人开始时间: 2007年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
89
主要终点
Mortality

研究概览

简要总结

The purpose is to study the correlation between systemic inflammation (serum levels of CRP, IL-1beta, IL-6 and TNF-alpha) or hyperhomocysteinemia and the increase of mortality, in a representative cohort of patients with chronic obstructive pulmonary disease (COPD).

Secondary purposes are:

  1. To confirm the increase of cardiovascular mortality and the importance of cardiovascular morbidity in patients with COPD,
  2. To establish the role of various genetic polymorphisms in the correlation between systemic inflammation and cardiovascular disorders observed in COPD,
  3. To search for acceleration of aging of cardiovascular system evaluated with carotid intima-media thickness when systemic inflammation markers are increased,
  4. To study the correlation between COPD risk factors (tobacco and other food factors), change of respiratory functional data and cardiovascular morbi-mortality. In this study cardiovascular morbi-mortality is defined by following disorders: ischemic cardiopathy, left-sided heart failure, cardiac arrhythmia and cerebrovascular accident. Diagnosis is confirmed with standard techniques and independently of this study. Results of clinical examination, ECG, echocardiography and /or brain scanner will be collected.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Actual or past active smoking of at least 20 packets/year
  • FEV1/FVC < 70%

排除标准

  • Co-morbidity except essential arterial hypertension controlled by treatment, stable coronary disease, type 2 diabetes and/or degenerative arthropathy (non-inflammatory rheumatic disorder)
  • Acute disorder during 8 weeks before inclusion, especially COPD worsening
  • Long-term corticosteroid or non-steroid anti-inflammatory treatment

结局指标

主要结局

Mortality

时间窗: 5 years

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

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