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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name