UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032690 |
|---|---|
| Receipt number | R000037281 |
| Scientific Title | Low Activities of Daily Living Associated with Increased Cardiovascular Disease Mortality in Japan: An Analysis of Health Records from a Nationwide Claim-Based Database, JROAD-DPC |
| Date of disclosure of the study information | 2018/05/23 |
| Last modified on | 2019/11/23 12:27:19 |
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Basic information
Public title
Low Activities of Daily Living Associated with Increased Cardiovascular Disease Mortality in Japan: An Analysis of Health Records from a Nationwide Claim-Based Database, JROAD-DPC
Acronym
Clinical impact of activities of daily living
Scientific Title
Low Activities of Daily Living Associated with Increased Cardiovascular Disease Mortality in Japan: An Analysis of Health Records from a Nationwide Claim-Based Database, JROAD-DPC
Scientific Title:Acronym
Clinical impact of activities of daily living
Region
| Japan |
Condition
Condition
acute coronary disease
heart failure
aortic disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform a nationwide claim survey using the DPC discharge database and to reveal the clinical impact of basal ADL on the prognosis of patients with cardiovascular diseases in a super-aged society.
Basic objectives2
Others
Basic objectives -Others
To investigate clinilal impact of ADL
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
in-hospital mortality
30-day mortality
7-day mortality
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
acute coronary syndrome
heart failure
aortic disease
Key exclusion criteria
scheduled admissions
Target sample size
200000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaomi Gohbara |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Division of cardiology
Zip code
Address
3-2-10, Kounandai, Kounan-ku, Yokohama, Japan
TEL
045-832-1111
gocchi3@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaomi Gohbara |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Division of cardiology
Zip code
Address
3-2-10, Kounandai, Kounan-ku, Yokohama, Japan
TEL
045-832-1111
Homepage URL
gocchi3@hotmail.com
Sponsor or person
Institute
Saiseikai Yokohamashi Nanbu Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
206643
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
| 2017 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The Japanese Registry of All Cardiac and Vascular Diseases (JROAD) was launched in 2004 to assess the clinical activity of each Japanese institution with cardiovascular beds. The Japanese Circulation Society publicly advertised for the research proposal using the JROAD and the JROAD-DPC. The present study was adopted as the 2016 research proposal (approval number: 2016-12-02).
Management information
Registered date
| 2018 | Year | 05 | Month | 23 | Day |
Last modified on
| 2019 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037281
| 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 |
