UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter prospective observational study to assess depression in patients with cardiovascular disease
Title of the study (Brief title)	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	Nobuhisa Hagiwara
Organization	Tokyo Women' Medical University
Division name	Cardiology
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	Tsuyoshi Shiga
Organization	Tokyo Women's Medical University
Division name	Cardiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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