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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023514
Receipt No. 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

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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
Email 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
Email mshiga@hij.twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027088

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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