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Clinical Trials/NCT02940275
NCT02940275
Completed
Not Applicable

Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases

National Taiwan University Hospital1 site in 1 country156 target enrollmentOctober 17, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
National Taiwan University Hospital
Enrollment
156
Locations
1
Primary Endpoint
Perfused small vessel density of sublingual small vessels measured by Cytocam
Status
Completed
Last Updated
7 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. Patients will received the examination of sublingual microcirculation by using incident dark field video microscope (Cytocam,Braedius Battery Powered Transilluminator). 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 kidney transplant recipients (60), group 6 coronary artery disease (60), and group 7 peripheral arterial occlusive disease (60).

Registry
clinicaltrials.gov
Start Date
October 17, 2016
End Date
September 1, 2018
Last Updated
7 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 hypertension \> 6 months, without other systemic diseases
  • Diagnosed diabetes mellitus \> 6 months, without other systemic diseases
  • Diagnosed with both hypertension and diabetes mellitus \> 6 months, without other systemic diseases
  • Diagnosed with end stage renal disease \> 6 months
  • Received renal replacement therapy \> 6 months
  • Diagnosed with coronary artery disease \> 6 months
  • Diagnosed with peripheral arterial occlusive diseases \> 6 months

Exclusion Criteria

  • Diagnosed with sepsis, major trauma, 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

Perfused small vessel density of sublingual small vessels measured by Cytocam

Time Frame: Once at enrollment

Secondary Outcomes

  • Total small vessel density of sublingual small vessels measured by Cytocam(Once at enrollment)

Study Sites (1)

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