UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062033 |
|---|---|
| Receipt number | R000070978 |
| Scientific Title | Investigation of Meteorological and Environmental Factors Associated with the Onset of Subarachnoid Hemorrhage |
| Date of disclosure of the study information | 2026/08/24 |
| Last modified on | 2026/06/23 18:10:31 |
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Basic information
Public title
Meteorological and Environmental Factors Associated with the Onset of Subarachnoid Hemorrhage
Acronym
ME-SAH Study
Scientific Title
Investigation of Meteorological and Environmental Factors Associated with the Onset of Subarachnoid Hemorrhage
Scientific Title:Acronym
ME-SAH Study
Region
| Japan |
Condition
Condition
subarachnoid hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to elucidate, through a case-crossover design, the causal relationship and lag effects between rapid decreases in apparent temperature, exposure to ambient air pollutants (PM2.5, NO2, and Ox), and the onset of spontaneous subarachnoid hemorrhage (SAH) in patients admitted to Tokushima University Hospital. In addition, we aim to determine whether susceptibility to meteorological and air environmental fluctuations differs according to aneurysm characteristics, including size, location, morphology (presence of blebs), and UCAS Japan risk stratification score, through interaction analyses. The ultimate goal is to provide evidence supporting the development of personalized preventive medicine for individuals at high risk of aneurysm rupture.
Basic objectives2
Others
Basic objectives -Others
This exploratory study aims to investigate the effects of meteorological and air pollution factors on the risk of subarachnoid hemorrhage (SAH), identify environmental determinants associated with disease onset, and facilitate risk stratification of susceptible populations.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
onset of spontaneous subarachnoid hemorrhage
Key secondary outcomes
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
This study will include patients with spontaneous subarachnoid hemorrhage (SAH) registered in the Tokushima University Hospital SCU database who were emergently transported to and admitted to the hospital between January 1, 2020, and September 30, 2025 (target sample size: 200). Cases with clearly identifiable onset date and time and residential address or location of onset in the medical records will be included.
Key exclusion criteria
1. Patients with traumatic subarachnoid hemorrhage (SAH).
2. Patients for whom the date and time of onset and/or residential location information are unavailable, making linkage with meteorological and environmental data impossible.
3. Patients for whom an explicit refusal to participate was expressed by the patient or their legally authorized representative through the opt-out process (e.g., information disclosure document) regarding the use of their information in this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Yakagi |
Organization
Tokushima University Hospital
Division name
Department of Neurosurgery
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima City, Tokushima Prefecture, Japan
TEL
088-633-7149
neuros@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Takagi |
Organization
Tokushima University Hospital
Division name
Department of Neurosurgery
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima City, Tokushima Prefecture, Japan
TEL
088-633-7149
Homepage URL
neuros@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
self-financing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1 Kuramoto-cho, Tokushima City, Tokushima Prefecture, Japan
Tel
088-615-8512
first-ec@tokushima-u.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center retrospective observational study using the Tokushima University Hospital Stroke Care Unit (SCU) database. Patients with spontaneous subarachnoid hemorrhage (SAH) who were emergently transported to and admitted to Tokushima University Hospital between January 1, 2020, and September 30, 2025, will be included.
A case-crossover design will be employed, with each patient serving as his or her own control. Information on the date and time of onset and place of residence (or location of onset) will be linked with meteorological data (including apparent temperature) and environmental data (including PM2.5, NO2, and Ox) to evaluate their associations with the risk of SAH onset and to assess potential lag effects.
Furthermore, stratified and interaction analyses will be performed based on aneurysm size, location, morphology (including the presence of blebs), and the UCAS Japan risk stratification score to investigate differences in aneurysm susceptibility to meteorological and environmental factors.
Management information
Registered date
| 2026 | Year | 06 | Month | 23 | Day |
Last modified on
| 2026 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070978
