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Clinical Trials/NCT02516215
NCT02516215
Unknown
Not Applicable

Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases

National Taiwan University Hospital1 site in 1 country360 target enrollmentSeptember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sublingual Microcirculation Status
Sponsor
National Taiwan University Hospital
Enrollment
360
Locations
1
Primary Endpoint
Total small vessel density of sublingual small vessels
Last Updated
9 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
January 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Total small vessel density of sublingual small vessels

Time Frame: Once at enrollment

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

Secondary Outcomes

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

Study Sites (1)

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