Sublingual Microcirculation of Healthy Volunteers by Usin... | NCT02412839

Studies
Sublingual Microcirculation of Healthy Volunteers by Using the Third Generation Microcirculation Video Microscope

NCT02412839

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Mar 4, 2019Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Feb 15, 2017Actual

Completion Date

Feb 28, 2017Actual

First Submitted Date

Apr 6, 2015

First Submission Date that Met QC Criteria

Apr 8, 2015

First Posted Date

Apr 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2019

Last Update Posted Date

Mar 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will enroll 150 healthy volunteers, and the grouping is as follows: group 20-39 (30 males and 30 females); group 40-59 (30 males and 30 females); and group 60-79 (15 males and 15 females). The sublingual microcirculation will be examined with the incident dark field video microscope (Cytocam，Braedius Battery Powered Transilluminator). The study aims to compare the differences of microcirculation among the three groups and between genders.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 20-39		Patients aged from 20 to 39 years old. 30 males and 30 females.
Group 40-59		Patients aged from 40 to 59 years old. 30 males and 30 females.
Group 60-79		Patients aged from 60 to 79 years old. 15 males and 15 females.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total small vessel density of sublingual small vessels measured by Cytocam	Total small vessel density will be measured by Cytocam	Once at enrollment

Secondary Outcomes

Measure	Description	Time Frame
Perfused small vessel density of sublingual small vessels measured by Cytocam	Perfused small vessel density will be measured by Cytocam	Once at enrollment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
- uncured cancer
- chronic uncontrolled infection
- other disease may limit daily activities
- non-native speakers

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy Volunteers

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yu-Chang Yeh, PhD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan