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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029719
Receipt No. 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 2019/10/28

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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
Email 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/
Email stroke@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

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
Email 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
2019 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.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


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