UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021454 |
|---|---|
| Receipt number | R000024741 |
| 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 |
| Date of disclosure of the study information | 2016/03/12 |
| Last modified on | 2019/03/15 13:04:06 |
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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
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
SeigoSugiyama@jinnouchi.or.jp
Public contact
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
SeigoSugiyama@jinnouchi.or.jp
Sponsor or person
Institute
Jinnouchi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024741
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
