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临床试验/NCT02516215
NCT02516215Unknown不适用

Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
360
试验地点
1
主要终点
Total small vessel density of sublingual small vessels

研究概览

简要总结

This is an observational clinical study, patients with systemic diseases will be enrolled according to the inclusion and exclusion criteria. 360 patients will received the examination of sublingual microcirculation by using sidestream dark filed video microscope. The microcirculation data includes total small vessel density, perfused small vessel density, microvascular flow index, and heterogeneity index. The patients will be divided into right groups according to their systemic diseases as follows: group 1 hypertension (60 patients), group 2 diabetes mellitus (60), group 3 hypertension and diabetes mellitus (60), group 4 end stage renal disease with hemodialysis (60), group 5 peripheral arterial occlusive disease (30), group 6 coronary artery disease (30), group 7 liver cirrhosis (30), and group 8 anemia (30).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged from 20 to 79 years old
  • BMI ranged from 18.5 to 27 kg/m2
  • Presence of one of the condition
  • Diagnosed hypertenison > 6 months, without other systemic diseases
  • Diagnosed diabetes mellitus > 6 monthes, without other systemic diseases
  • Diagnosed with both hypertension and diabetes mellitus > 6 months, without other systemic diseases
  • Diagnosed with end stage renal disease and recevied renal replacement therapy > 6 months
  • Diagnosed with peripheral arterial occlusive diseases > 6 months
  • Diagnosed with coronary artery disease > 6 months
  • Diagnosed with liver cirrhosis > 6 months
  • Diagnosed with anemia > 6 months, hemoglobin level < 10 g/dL

排除标准

  • Diagnosed with sepsis, major tauma, or admission to ICU within one month
  • Body temperature higher than 37.5 ℃ or lower than 35.5 ℃
  • Any on of the following condition
  • Chronic obstructive pulmonary disease
  • Endocrine diseases
  • Hematological disorders
  • Uncured cancer
  • Chronic uncured infection
  • Other major disease with limited daily activity
  • Non-native speakers

结局指标

主要结局

Total small vessel density of sublingual small vessels

时间窗: Once at enrollment

Total small vessel density will be measured by Microscan and analyzed by AVA 3.0 software

次要结局

  • Perfused small vessel density of sublingual small vessels(Once at enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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