UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029719 |
|---|---|
| Receipt number | R000033960 |
| Scientific Title | Shiga Comprehensive Population-based Cardiovascular Disease (including Stroke) Registries |
| Date of disclosure of the study information | 2017/10/26 |
| Last modified on | 2020/04/28 10:23:34 |
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Basic information
Public title
Shiga Comprehensive Population-based Cardiovascular Disease (including Stroke) Registries
Acronym
Shiga Stroke Registry
Scientific Title
Shiga Comprehensive Population-based Cardiovascular Disease (including Stroke) Registries
Scientific Title:Acronym
Shiga Stroke Registry
Region
| Japan |
Condition
Condition
stroke, ischemic herat disease, aortic disease
Classification by specialty
| Cardiology | Neurology | Vascular surgery |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the quality of medical care of cardiovascular disease (including stroke) patients by using QIs and population-based registry databases
Basic objectives2
Others
Basic objectives -Others
To develop new QI for a CVD medical care system
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Sex/age-adjusted mortality
Key secondary outcomes
Functional outcome
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
All stroke, ischemic heart disease, aortic disease
Key exclusion criteria
none
Target sample size
8000
Research contact person
Name of lead principal investigator
| 1st name | Nozaki |
| Middle name | |
| Last name | Kazuhiko |
Organization
Shiga University of Medical Science
Division name
Department of Neurosurgery
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-2257
noz@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Nozaki |
| Middle name | |
| Last name | Kazuhiko |
Organization
Shiga Stroke Data Center
Division name
Department of Neurosurgery
Zip code
520-2192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
077-548-3631
Homepage URL
https://cera.shiga-med.ac.jp/ssdac/
stroke@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shiga prefecture
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Seta Tsukinowacho
Tel
0775483576
hqrec@belle.shiga-med.ac.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
滋賀医科大学附属病院（滋賀県）、県内病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 26 | Day |
Related information
URL releasing protocol
https://cera.shiga-med.ac.jp/ssdac/format.html
Publication of results
Unpublished
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Educated researchers register patient's data on site-visit.
Management information
Registered date
| 2017 | Year | 10 | Month | 26 | Day |
Last modified on
| 2020 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033960
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
