UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008598 |
|---|---|
| Receipt number | 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 17:52:23 |
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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
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
hashiguchi@cvi.or.jp
Sponsor or person
Institute
The Cardiovascular Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010098
| Research Plan | |
|---|---|
| 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 |
