UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039962 |
|---|---|
| Receipt number | R000045530 |
| Scientific Title | The multicenter long-term study of the relationship between the change in the incident of subarachnoid hemorrhage and lifestyle habit in Japan |
| Date of disclosure of the study information | 2020/03/30 |
| Last modified on | 2020/03/25 00:19:50 |
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Basic information
Public title
The multicenter long-term study of the relationship between the change in the incident of subarachnoid hemorrhage and lifestyle habit in Japan
Acronym
Japan Incidence of SAH study (JIS study)
Scientific Title
The multicenter long-term study of the relationship between the change in the incident of subarachnoid hemorrhage and lifestyle habit in Japan
Scientific Title:Acronym
Japan Incidence of SAH study (JIS study)
Region
| Japan |
Condition
Condition
subarachnoid hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the etiology of the change by investigation of the incidence of subarachnoid hemorrhage
Basic objectives2
Others
Basic objectives -Others
To reduce the incidence of subarachnoid hemorrhage in Japan to the same level as western countries
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The change in incidence of subarachnoid hemorrhage in Japan
Key secondary outcomes
hypertension, smoking
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
| 1 | years-old | < |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All treated patients with subarachnoid hemorrhage
Key exclusion criteria
non-aneurysmal subarachnoid hemorrhage
Target sample size
450000
Research contact person
Name of lead principal investigator
| 1st name | Fusao |
| Middle name | |
| Last name | Ikawa |
Organization
Shimane Prefectural Central Hospital
Division name
Department of Neurosurgery
Zip code
693-8555
Address
4-1-1 Himebara, Izumo City, Shimane
TEL
0853-22-5111
fikawa-nsu@umin.ac.jp
Public contact
Name of contact person
| 1st name | Fusao |
| Middle name | |
| Last name | Ikawa |
Organization
Shimane Prefectural Central Hospital
Division name
Department of Neurosurgery
Zip code
693-8555
Address
4-1-1 Himebara, Izumo City, Shimane
TEL
0853-22-5111
Homepage URL
fikawa-nsu@umin.ac.jp
Sponsor or person
Institute
Shimane Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science, Grant-in-Aid for Scientific Research (C) 17K10829
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane Prefectural Central Hospital, Clinical Research and Trial Management Center
Address
4-1-1 Himebara, izumo, shimane
Tel
0853225111
chiken@spch.izumo.shimane.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
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
| 1999 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Under analysis and before open
Management information
Registered date
| 2020 | Year | 03 | Month | 27 | Day |
Last modified on
| 2020 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045530
