UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000010098