UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051140 |
|---|---|
| Receipt number | R000058325 |
| Scientific Title | Joint study on the development of preventive methods for active cardiovascular disease, cerebrovascular disease, and renal disease by vascular endothelial function examination(Second year continuation test) |
| Date of disclosure of the study information | 2023/06/27 |
| Last modified on | 2024/04/18 11:21:04 |
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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(Second year continuation test)
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 EndoPAT test.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
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
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
mterauchi@hubitgenomix.com
Sponsor or person
Institute
HuBit genomix,Inc.
Institute
Department
Personal name
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
03-5148-3990
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
| 2023 | Year | 06 | Month | 27 | 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
341
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
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 03 | 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
| 2023 | Year | 05 | Month | 23 | Day |
Last modified on
| 2024 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058325
| 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 |
