跳至主要内容
临床试验/NCT03017625
NCT03017625Unknown不适用

Platelet Activation and Responsiveness in Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AE-COPD)

Radboud University Medical Center0 个研究点目标入组 30 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Platelet activation: platelet expression of CD62P (P-selectin) and fibrinogen binding at baseline and upon ex vivo stimulation.

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is known for development of severe cardiovascular co-morbidities. Systemic inflammation during acute exacerbations of COPD (AE-COPD) is thought to play a role in development of cardiovascular disease. Platelets contribute to acute cardiovascular events and atherosclerosis. When platelets are activated, they form complexes with monocytes. These platelet-monocyte complexes (PMCs) are an early process in atherothrombosis and promote inflammation. In COPD, platelet function in AE-COPD is scarcely studied. This study aims to address this gap by investigating platelet function and coagulation in patients with AE-COPD and after convalescence.

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
40 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >40 years
  • Spirometry confirmed diagnosis of COPD (i.e. post-bronchodilator FEV1/FVC < 70% and less than 12% on reversibility testing< Lower limit of normal (LLN))
  • ≥10 pack years of smoking

排除标准

  • Use of anti-coagulation or other platelet function inhibitors
  • Chronic inflammatory diseases, for example rheumatoid arthritis, psoriasis, inflammatory bowel diseases , systemic lupus erythematous (SLE)
  • Malignancies

结局指标

主要结局

Platelet activation: platelet expression of CD62P (P-selectin) and fibrinogen binding at baseline and upon ex vivo stimulation.

时间窗: Measured at presentation with an AE-COPD and after 8 weeks

次要结局

  • Platelet-monocyte interaction (CD14 cells positive for CD61)(Measured at presentation with an AE-COPD and after 8 weeks)
  • Monocyte activation (CD11b expression on CD14 positive cells)(Measured at presentation with an AE-COPD and after 8 weeks)
  • Plasma markers: Interleukin-6, Interleukin-8, high sensitive-CRP, soluble P-selectin, soluble Fibrinogen, D-dimer(Measured at presentation with an AE-COPD and after 8 weeks)
  • Tissue factor triggered thrombin generation capacity(Measured at presentation with an AE-COPD and after 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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