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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008598
Receipt No. R000010098
Scientific Title A Prospective Cohort Study of Cardiovascular Diseases in a Cardiovascular Hospital in an Urban Area of Japan
Date of disclosure of the study information 2012/09/01
Last modified on 2020/06/17

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Basic information
Public title A Prospective Cohort Study of Cardiovascular Diseases in a Cardiovascular Hospital in an Urban Area of Japan
Acronym Shinken Database Cohort Study
Scientific Title A Prospective Cohort Study of Cardiovascular Diseases in a Cardiovascular Hospital in an Urban Area of Japan
Scientific Title:Acronym Shinken Database Cohort Study
Region
Japan

Condition
Condition Cardiovascular Diseases
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To invesgate the prognosis of cardiovascular diseases in a cardiovascular hospital in an urban area of Japan.
Basic objectives2 Others
Basic objectives -Others The present prospective cohort study includes all the new patients visiting the Cardiovascular Institute (Tokyo, Japan) since June 2004. After obtaining the patients' data at first visit, the health status and the incidence of cardiovascular events
and mortality are maintained in the database by being linked to the medical records of the hospital, and by study documents of prognosis sent once per year to those who stopped hospital visits or who were referred to other hospitals.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Mortality, Admission with cardiovascular diseases
Key secondary outcomes Admission without cardiovascular diseases

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria New patients of the Cardiovascular Institute since June 2004
Key exclusion criteria patients with active cancer, foreign travellers
Target sample size 30000

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Yamashita
Organization The Cardiovascular Institute
Division name Director
Zip code 106-0031
Address 3-2-19 Nishiazabu, Minato-Ku, Tokyo
TEL 03-3408-2151
Email yamt-tky@umin.ac.jp

Public contact
Name of contact person
1st name Yurika
Middle name
Last name Hashiguchi
Organization The Cardiovascular Institute
Division name The management office of Shinken Database
Zip code 106-0031
Address 3-2-19 Nishiazabu, Minato-Ku, Tokyo
TEL 03-3408-2151
Homepage URL http://www.cvi.or.jp/z-zaidan-kenkyu.html
Email hashiguchi@cvi.or.jp

Sponsor
Institute The Cardiovascular Institute
Institute
Department

Funding Source
Organization The Cardiovascular Institute
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Committee of The Cardiovascular Institute
Address Nishi-azabu 3-2-19, Minato-ku, Tokyo
Tel 03-3408-2151
Email matsuda@cvi.or.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 心臓血管研究所付属病院(東京都)/ The Cardiovascular Institute (Tokyo)

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 01 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 Open public recruiting
Date of protocol fixation
2004 Year 04 Month 01 Day
Date of IRB
2004 Year 05 Month 27 Day
Anticipated trial start date
2004 Year 06 Month 01 Day
Last follow-up date
2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In Shinken Database, 23348 patients (male 14667, female 8681) have been registered untill March 2019. At that time, the database included 3969 ischemic heart disease, 2624 valvular heart disease, 1699 cardioyopathy, 3098 heart failure and 3855 atrial fibrillation.

Management information
Registered date
2012 Year 08 Month 02 Day
Last modified on
2020 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010098

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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