UMIN-CTR Clinical Trial

Basic information
Public title	Multi-center study for evaluating distribution of RHI in Japanese subjects without cardiovascular diseases for estimating clinical reference value of RHI in Japan
Acronym	Multi-center study for evaluating distribution of RHI in Japanese subjects without cardiovascular diseases for estimating clinical reference value of RHI in Japan (RHI-J Non-CVD Study)
Scientific Title	Multi-center study for evaluating distribution of RHI in Japanese subjects without cardiovascular diseases for estimating clinical reference value of RHI in Japan
Scientific Title:Acronym	Multi-center study for evaluating distribution of RHI in Japanese subjects without cardiovascular diseases for estimating clinical reference value of RHI in Japan (RHI-J Non-CVD Study)
Region	Japan

Condition
Condition	healthy subjects and out-patients without cardiovascular diseases
Classification by specialty	Medicine in general Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish the reference value of RHI in Japanese subjects without cardiovascular diseases
Basic objectives2	Others
Basic objectives -Others	Follow-up all subjects until the occurrence of cardiovascular events
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	distribution of RHI values in subjects without clinical history of cardiovascular diseases (primary prevention)
Key secondary outcomes	relation between CV risk factors and RHI values relation between the baseline RHI values and CV events during follow-up period (2 years)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	healthy subjects or subjects without cardiovascular diseases
Key exclusion criteria	history of cardiovascular diseases hemodialysis unstable clinical condition (severe liver disease, cancer, inflammatory disease, immune disease, severe dementia, advanced organ damage etc) absence of fingers in both hands diastolic hypotension (dBP<40 mmHg)
Target sample size	10000

Research contact person
Last name of lead principal investigator	1st name Seigo Middle name Last name Sugiyama
Organization	Cardiovascular Medicine, Diabetes Care Center, Jinnouchi Hospital
Division name	Cardiovascular Medicine
Zip code	862-0976
Address	6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL	096-363-0011
Email	SeigoSugiyama@jinnouchi.or.jp

Public contact
1st name of contact person	1st name Seigo Middle name Last name Sugiyama
Organization	Cardiovascular Medicine, Diabetes Care Center, Jinnouchi Hospital
Division name	Cardiovascular Medicine
Zip code	862-0976
Address	6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL	096-363-0011
Homepage URL
Email	SeigoSugiyama@jinnouchi.or.jp

Sponsor
Institute	Jinnouchi Hospital
Institute
Department

Funding Source
Organization	Nexis Ltd.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Jinnouchi Hospital
Address	6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
Tel	096-363-0011
Email	hisyo@jinnouchi.or.jp

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	陣内病院

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 12 Day

Related information
URL releasing protocol	We did not publish protocol.
Publication of results	Unpublished

Result
URL related to results and publications	We did not publish protocol.
Number of participants that the trial has enrolled	20
Results	We could not enroll enough cases.
Results date posted	2019 Year 03 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	non CVD cases: 20
Participant flow	Terminated
Adverse events	none
Outcome measures	not assessed
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 04 Month 01 Day
Date of IRB	2015 Year 03 Month 30 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date	2017 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study design: cohort study Study subjects: patients visit Jinnouchi Hospital from July 2015 patients matched to enrollment criteria all patients agree to perform RH-PAT test measurement factors: RH-PAT, height, weight, waist circumference, lipid parameters, CRP etc.

Management information
Registered date	2016 Year 03 Month 12 Day
Last modified on	2019 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024741