HealthyNCT02359682
Population Research of Sublingual Microcirculation Data of Healthy Volunteers
An observational study of Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study will enrolled 90 healthy volunteers. The sublingual microcirculation will be examined by sidestreamdark-field videomicroscopy (MicroScan;Microvision Medical, Amsterdam, The Netherlands). Read more about this study
- Who is it for?
- Ages 20 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers
Who may be able to join
- Healthy volunteers aged from 20 to 79 years old
- BMI ranged from 18.5 to 27 kg/m2
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital, anesthesiology department
Taipei, 100
About this study
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).
- Conditions
- Healthy
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Age 20-39 | Patients aged from 20 to 39 years old. Receives: Other: No intervention | |
| Age 40-59 | Patients aged from 40 to 59 years old. Receives: Other: No intervention | |
| Age 60-79 | Patients aged from 60 to 79 years old. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total small vessel density of sublingual small vessels
Total small vessel density will be measured by Microscan and analyzed by AVA 3.0 software.
Measured: Once at enrollment
Secondary outcomes (1)
Perfused small vessel density of sublingual small vessels
Perfused small vessel density will be measured by Microscan and analyzed by AVA 3.0 software.
Measured: Once at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chang Yeh, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359682
- Sponsor's protocol ID
- 201409057RIN
- Status last verified
- Aug 2015
- First submitted
- 5 Nov 2014
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Research of Sublingual Microcirculation Data of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02359682
- Acronym / sponsor ID
- 201409057RIN
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Age 20-39 | – | Other: No interventionPatients aged from 20 to 39 years old. |
| Age 40-59 | – | Other: No interventionPatients aged from 40 to 59 years old. |
| Age 60-79 | – | Other: No interventionPatients aged from 60 to 79 years old. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers
Key inclusion criteria (2 listed)
- Healthy volunteers aged from 20 to 79 years old
- BMI ranged from 18.5 to 27 kg/m2
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo Intervention | Other | Age 20-39, Age 40-59, Age 60-79 |
Primary outcome
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.
1 secondary outcome
Perfused small vessel density of sublingual small vessels
Time frame: Once at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chang Yeh, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total small vessel density of sublingual small vessels (time frame: Once at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.