NCT02359682

Brief Summary

This study will enrolled 90 healthy volunteers. The sublingual microcirculation will be examined by sidestreamdark-field videomicroscopy (MicroScan;Microvision Medical, Amsterdam, The Netherlands). Five video sequences (20 s) was obtained from different sublingual sites, and digitally stored the images with code numbers that did not reflect volunteers' information for later offline analysis by automated analysis software (AVA 3.0; Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

8 months

First QC Date

November 5, 2014

Last Update Submit

August 11, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Total small vessel density of sublingual small vessels

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

    Once at enrollment

Secondary Outcomes (1)

  • Perfused small vessel density of sublingual small vessels

    Once at enrollment

Study Arms (3)

Age 20-39

Patients aged from 20 to 39 years old.

Other: No intervention

Age 40-59

Patients aged from 40 to 59 years old.

Other: No intervention

Age 60-79

Patients aged from 60 to 79 years old.

Other: No intervention

Interventions

No interventionOTHER

No Intervention

Age 20-39Age 40-59Age 60-79

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy Volunteers

You may qualify if:

  • Healthy volunteers aged from 20 to 79 years old
  • BMI ranged from 18.5 to 27 kg/m2

You may not qualify if:

  • Systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 95 mm Hg, or systolic blood pressure \< 90 mm Hg at enrollment
  • Body temperature \> 37.5 ℃ or \< 35.5 ℃ at enrollment
  • had been diagnose with any one of the following diseases
  • hypertension
  • diabetes mellitus
  • peripheral arterial occlusive disease
  • coronary arterial disease
  • liver cirrhosis
  • chronic kidney disease
  • stroke
  • anemia
  • asthma
  • chronic bronchitis
  • any metabolic diseases
  • any hematologic disease
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital, anesthesiology department

Taipei, 100, Taiwan

Location

Study Officials

  • Yu-Chang Yeh, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2014

First Posted

February 10, 2015

Study Start

October 1, 2014

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

TW(1)