UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026591 |
|---|---|
| Receipt number | R000030534 |
| Scientific Title | Noncontact measurement of central blood pressure using digital color images |
| Date of disclosure of the study information | 2017/03/21 |
| Last modified on | 2017/05/19 11:43:32 |
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Basic information
Public title
Noncontact measurement of central blood pressure using digital color images
Acronym
Noncontact measurement of central blood pressure
Scientific Title
Noncontact measurement of central blood pressure using digital color images
Scientific Title:Acronym
Noncontact measurement of central blood pressure
Region
| Japan |
Condition
Condition
Cerebrovascular disease and cardiovascular disease
Classification by specialty
| Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to conduct basic studies into the noncontact measurement of central blood pressure. The system consists of a RGB (red, green, and blue) camera and blood volume and hemodynamics is estimated from the digital color images of human skin. If the blood pressure can be measured using the camera, the blood pressure, which have relate to cardiovascular disease, can be monitored at home.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Digital color images of human skin are measured using a digital color camera at the same time that the central blood pressure (central BP) is measured using conventional central blood pressure measurement system. The relationship between central BP and the pulse wave component estimated from color images is investigated.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Digital color images of human skin are measured using a digital color camera at the same time that the central blood pressure (central BP) is measured using conventional system (SphygmoCor EXCEL). It takes about 15 minutes per person for the measurement.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects without vascular disease
Key exclusion criteria
Subjects with vascular disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Kikuchi |
Organization
Tokyo University of Science
Division name
Faculty of Science, Division 2
Zip code
Address
1-3, Kagurazaka, Shinjuku-ku, Tokyo
TEL
03-5228-8173
kikuchi@rs.kagu.tus.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Kikuchi |
Organization
Tokyo University of Science
Division name
Faculty of Science. Division 2
Zip code
Address
1-3, Kagurazaka, Shinjuku-ku, Tokyo
TEL
03-5228-8173
Homepage URL
kikuchi@rs.kagu.tus.ac.jp
Sponsor or person
Institute
Tokyo University of Science
Institute
Department
Personal name
Funding Source
Organization
JAPAN SOCIETY FOR THE PROMOTION OF SCIENCE
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 17 | Day |
Last modified on
| 2017 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030534
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| Registered date | File name |
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| Registered date | File name |
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