UMIN-CTR Clinical Trial

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
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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
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Research case data
Registered date	File name

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