UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023514 |
|---|---|
| Receipt number | R000027088 |
| Scientific Title | A multicenter prospective observational study to assess depression in patients with cardiovascular disease |
| Date of disclosure of the study information | 2016/08/05 |
| Last modified on | 2016/08/05 22:02:29 |
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Basic information
Public title
A multicenter prospective observational study to assess depression in patients with cardiovascular disease
Acronym
A multicenter prospective observational study to assess depression in patients with cardiovascular disease
Scientific Title
A multicenter prospective observational study to assess depression in patients with cardiovascular disease
Scientific Title:Acronym
A multicenter prospective observational study to assess depression in patients with cardiovascular disease
Region
| Japan |
Condition
Condition
Patients with cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prevalence of depression assessed by PHQ-9 and the effect of depression on adverse cardiovascular outcome in Japanese outpatients with cardiovascular disease.
Basic objectives2
Others
Basic objectives -Others
Risk assessment
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of depression
Key secondary outcomes
A composite of death from any cause or cardiovascular events
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
Patients with cardiovascular disease
Patients who are able to read and understand Japanese questionnaire
Patients who gave written consent
Key exclusion criteria
Patients who can't recieve psychological assessment because of their mental or pysical disablity
Patients with vision difficulty who have difficulty completing a paper questionnaire.
Judgement by attending physician that patient participation would be inappropriate.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhisa Hagiwara |
Organization
Tokyo Women' Medical University
Division name
Cardiology
Zip code
Address
Kawada-cho 8-1, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
mhagi@hij.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Shiga |
Organization
Tokyo Women's Medical University
Division name
Cardiology
Zip code
Address
Kawada-cho 8-1, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
mshiga@hij.twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japana
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
東京女子医科大学病院（東京都）
東京女子医科大学東医療センター（東京都）
東京女子医科大学青山病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 03 | Day |
Other
Other related information
The result of this study was presented in part to the 80the Annual Scientific Meeting of the Japanese Circulation Society.
Management information
Registered date
| 2016 | Year | 08 | Month | 05 | Day |
Last modified on
| 2016 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027088
| Research Plan | |
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| 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 |
