UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Noncontact measurement of central blood pressure using digital color images
Title of the study (Brief title)	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	Yasushi Kikuchi
Organization	Tokyo University of Science
Division name	Faculty of Science, Division 2
Address	1-3, Kagurazaka, Shinjuku-ku, Tokyo
TEL	03-5228-8173
Email	kikuchi@rs.kagu.tus.ac.jp

Public contact
Name of contact person	Yasushi Kikuchi
Organization	Tokyo University of Science
Division name	Faculty of Science. Division 2
Address	1-3, Kagurazaka, Shinjuku-ku, Tokyo
TEL	03-5228-8173
Homepage URL
Email	kikuchi@rs.kagu.tus.ac.jp

Sponsor
Institute	Tokyo University of Science
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 01 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030534