UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036754 |
|---|---|
| Receipt number | R000041883 |
| Scientific Title | The relationship between vascular function and health checkup data in local residents |
| Date of disclosure of the study information | 2019/05/16 |
| Last modified on | 2019/05/15 14:31:56 |
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Basic information
Public title
The relationship between vascular function and health checkup data in local residents
Acronym
The relationship between vascular function and health checkup data in local residents
Scientific Title
The relationship between vascular function and health checkup data in local residents
Scientific Title:Acronym
The relationship between vascular function and health checkup data in local residents
Region
| Japan |
Condition
Condition
Vascular dysfunction
Frailty
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to evaluate the relationship of vascular dysfunction with flailty onset using health examination data.
Basic objectives2
Others
Basic objectives -Others
Factors for predicting vascular dysfunction and flailty onset
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of flailty
Key secondary outcomes
1) Development of renal dysfunction
2) Incident of metabolic syndrome
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects who have two days medical health checkup at Gunma chuo hospital
Key exclusion criteria
The subjects who do not agree to participate in this study
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Ohyama |
Organization
Gunma University Hospital
Division name
Clinical Investigation and Research Unit
Zip code
3710034
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan
TEL
0272208740
yoshiaki-ohyama@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Mie |
| Middle name | |
| Last name | Araki |
Organization
Japan Community Health care Organization Gunma Chuo Hospital
Division name
Department of Pharmacy
Zip code
3710025
Address
1-7-13 Kouncho, Maebashi, Gunma, Japan
TEL
0272218165
Homepage URL
araki-mie@gunma.jcho.go.jp
Sponsor or person
Institute
Japan Community Health care Organization Gunma Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society For Promotion Of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Takasaki University of Health and Welfare
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Community Health care Organization Gunma Chuo Hospita
Address
1-7-13 Kouncho, Maebashi, Gunma, Japan
Tel
0272218165
chiken@gunma.jcho.go.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study consisting of cross-sectional study followed by longitudinal study.
In addition to the usual health checkup data, the next check is performed.
CAVI (Cardio Ankle Vascular Index), ABI (Ankle Brachial Pressure Index), urinary sodium concentration, urinary creatinine, central blood pressure, 24-hour blood pressure, medication survey, activity survey, preference survey, flail index test
Management information
Registered date
| 2019 | Year | 05 | Month | 15 | Day |
Last modified on
| 2019 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041883
| 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 |
