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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000048118
Receipt No. R000054834
Scientific Title Joint study on the development of preventive methods for active cardiovascular disease, cerebrovascular disease, and renal disease by vascular endothelial function examination
Date of disclosure of the study information 2022/06/23
Last modified on 2022/06/27

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Basic information
Public title Arita-cho Vascular Endothelial Function Study
Acronym Arita-cho study
Scientific Title Joint study on the development of preventive methods for active cardiovascular disease, cerebrovascular disease, and renal disease by vascular endothelial function examination
Scientific Title:Acronym Joint study of vascular endothelial function
Region
Japan

Condition
Condition NONE
Classification by specialty
Medicine in general Cardiology Nephrology
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In addition to conventional medical examinations, non-invasive vascular endothelial function tests are conducted for the purpose of preventing cardiovascular diseases, cerebrovascular diseases, renal diseases, etc. associated with lifestyle-related diseases, and health examination information and lifestyle information of each inhabitant. And establish health guidance methods, treatment methods, and preventive methods that are suitable for each individual.
Basic objectives2 Others
Basic objectives -Others Examination of reference values for vascular endothelial function by Endo-PAT test.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes vascular endothelial function
Key secondary outcomes Chiral amino acids

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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Among the group health examination examinees conducted by Arita Town, those who have obtained informed consent
2. Men and women over 30 years old
Key exclusion criteria 1. If your arm tends to swell or bleed
2. When a blood clot can form a blood clot
3. When using antithrombotic agent
4. When the blood clad can cause peripheral circulatory disorders
5. If you are taking other medicines that affect blood vessels
6. When the doctor judges that it is inappropriate due to poor physical condition etc.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Tomomi
Middle name
Last name Ide
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Immunoregulatory Cardiovascular Medicine
Zip code 812-8582
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL 092-642-5360
Email ide.tomomi.117@m.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Masako
Middle name
Last name Terauchi
Organization HuBit genomix,Inc.
Division name Business Department
Zip code 104-0045
Address 7-10-2 Tukiji,Chuo-ku,Tokyo,104-0045 Japan
TEL 03-5148-3990
Homepage URL
Email mterauchi@hubitgenomix.com

Sponsor
Institute HuBit genomix,Inc.
Institute
Department

Funding Source
Organization HuBit genomix,Inc.
TOYO SHINYAKU Co.,Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization HuBit genomix,Inc.
Address 7-10-2 Tukiji,Chuo-ku,Tokyo,104-0045 Japan
Tel 0351483990
Email mterauchi@hubitgenomix.com

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
2022 Year 06 Month 23 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 Enrolling by invitation
Date of protocol fixation
2022 Year 05 Month 10 Day
Date of IRB
2022 Year 05 Month 12 Day
Anticipated trial start date
2022 Year 06 Month 23 Day
Last follow-up date
2022 Year 08 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cohort study
The vascular endothelial function is measured by the Endo-PAT test, and the reference value is obtained.
Evaluate the relationship with clinical laboratory test values and chiral amino acids obtained in medical examinations.

Management information
Registered date
2022 Year 06 Month 21 Day
Last modified on
2022 Year 06 Month 27 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054834

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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