UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055802 |
|---|---|
| Receipt number | R000063770 |
| Scientific Title | Contribution of oral medicine to the progression and rupture of intracranial aneurysm |
| Date of disclosure of the study information | 2024/10/10 |
| Last modified on | 2025/04/11 11:18:05 |
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Basic information
Public title
Contribution of oral medicine to the progression and rupture of intracranial aneurysm
Acronym
Investigation of the pathogenesis of intracranial aneurysm
Scientific Title
Contribution of oral medicine to the progression and rupture of intracranial aneurysm
Scientific Title:Acronym
Investigation of the pathogenesis of intracranial aneurysm
Region
| Japan |
Condition
Condition
Intracranial aneurysm, Subarachnoid hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the association between the pathogenesis of intracranial aneurysm and the oral medication using data held by Saitama Medical University International Medical Center and BioBank Japan.
Basic objectives2
Others
Basic objectives -Others
To clarify the association between the pathogenesis of intracranial aneurysm and the oral medication
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnosis, age, gender, present history, past history, history of oral medication, taste, symptom at admission, laboratory data, radiological finding, therapeutic course, and outcome.
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
Patients with intracranial aneurysm or subarachnoid hemorrhage admitted to Saitama Medical University International Medical Center.
Data of cases with intracranial aneurysm or subarachnoid hemorrhage held by BioBank Japan.
Key exclusion criteria
Patients without history of oral medication.
Target sample size
6800
Research contact person
Name of lead principal investigator
| 1st name | Tomomichi |
| Middle name | |
| Last name | Kayahara |
Organization
Saitama Medical University International Medical Center
Division name
Department of Cerebrovascular Surgery
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama, Japan
TEL
042-984-4111
t_kayahara@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomomichi |
| Middle name | |
| Last name | Kayahara |
Organization
Saitama Medical University International Medical Center
Division name
Department of Cerebrovascular Surgery
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama, Japan
TEL
042-984-4111
Homepage URL
t_kayahara@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center, CCRI
Address
1397-1 Yamane, Hidaka, Saitama, Japan
Tel
042-984-4111
chikens@saitama-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Retrospective study
Management information
Registered date
| 2024 | Year | 10 | Month | 10 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063770
