UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037542 |
|---|---|
| Receipt number | R000042806 |
| Scientific Title | The effects of fine particles on cardiopulmonary function in the working environment |
| Date of disclosure of the study information | 2019/07/31 |
| Last modified on | 2021/03/23 12:03:20 |
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Basic information
Public title
The effects of fine particles on cardiopulmonary function in the working environment
Acronym
The effects of fine particles on cardiopulmonary function in the working environment
Scientific Title
The effects of fine particles on cardiopulmonary function in the working environment
Scientific Title:Acronym
The effects of fine particles on cardiopulmonary function in the working environment
Region
| Japan | Asia(except Japan) |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study is aimed to examine the effects of fine particles on cardiopulmonary function in the working environment.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate variability by Holter ECG and atherosclerosis by ankle-brachial pressure index
Key secondary outcomes
Parameters of medical examination including respiratory function by spirometer
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement of Holter ECG during work or ankle-brachial pressure index before and after work
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Workers at the factories for the survey
Key exclusion criteria
Pregnant women or irregularly employed workers
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Sahoko |
| Middle name | |
| Last name | ICHIHARA |
Organization
Jichi Medical University
Division name
Department of Environmental and Preventive Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, JAPAN
TEL
+81285587335
saho@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Sahoko |
| Middle name | |
| Last name | ICHIHARA |
Organization
Jichi Medical University
Division name
Department of Environmental and Preventive Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, JAPAN
TEL
+81285587335
Homepage URL
saho@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hospital for Occupational Diseases Control of Guangdong Province
Mie University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Clinical Research Ethics Committee
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, JAPAN
Tel
+81285588933
rinri@jichi.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 31 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 30 | Day |
Last modified on
| 2021 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042806
