UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036754
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email araki-mie@gunma.jcho.go.jp

Sponsor
Institute Japan Community Health care Organization Gunma Chuo Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041883

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.