UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050418 |
|---|---|
| Receipt number | R000057412 |
| Scientific Title | COhort study of Life-environment and Diseases to examine a cold debt |
| Date of disclosure of the study information | 2023/03/17 |
| Last modified on | 2024/02/24 12:06:32 |
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Basic information
Public title
COhort study of Life-environment and Diseases to examine a cold debt
Acronym
COLD Debt Study
Scientific Title
COhort study of Life-environment and Diseases to examine a cold debt
Scientific Title:Acronym
COLD Debt Study
Region
| Japan |
Condition
Condition
Cardiovascular diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine "cold debt: accumulation of damage to blood vessels due to long-term residence in cold housing"
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cardio-Ankle Vascular Index: CAVI
Key secondary outcomes
Ankle Brachial Pressure Index: ABI
Onset of cardiovascular diseases
Onset of hypertension
Treatment with antihypertensive drugs
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents who measure arteriosclerosis (Cardio-Ankle Vascular Index: CAVI) at a health checkup facility
Key exclusion criteria
Residents who move to their new houses during follow-up period
Residents who improve their houses' thermal insulation level during follow-up period
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Umishio |
Organization
Tokyo Institute of Technology
Division name
Department of Architecture and Building Engineering, School of Environment and Society
Zip code
152-8552
Address
W8-11, 2-12-1, Ookayama, Meguro-ku, Tokyo
TEL
03-5734-2908
umishio.w.aa@m.titech.ac.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Umishio |
Organization
Tokyo Institute of Technology
Division name
Department of Architecture and Building Engineering, School of Environment and Society
Zip code
152-8552
Address
W8-11, 2-12-1, Ookayama, Meguro-ku, Tokyo, Japan
TEL
03-5734-2908
Homepage URL
umishio.w.aa@m.titech.ac.jp
Sponsor or person
Institute
Tokyo Institute of Technology
Institute
Department
Personal name
Wataru Umishio
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hitachi Health Care Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Institute of Technology's Human Subjects Research Ethics Review Committee
Address
E3-10, 2-12-1 Ookayama, Meguro-ku, Tokyo, Japan
Tel
03-5734-3808
hitorinri@jim.titech.ac.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
(株)日立製作所 日立健康管理センタ/Hitachi Health Care Center
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 17 | 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
| 2022 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2031 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2034 | Year | 03 | Month | 31 | Day |
Other
Other related information
Cohort study
Management information
Registered date
| 2023 | Year | 02 | Month | 23 | Day |
Last modified on
| 2024 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057412
| 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 |
