UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004864 |
|---|---|
| Receipt number | R000005427 |
| Scientific Title | To establish detecting central nerve resion among vertigo patients in the emergency department |
| Date of disclosure of the study information | 2011/01/13 |
| Last modified on | 2022/04/06 16:34:32 |
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Basic information
Public title
To establish detecting central nerve resion among vertigo patients in the emergency department
Acronym
To establish detecting central vertigo
Scientific Title
To establish detecting central nerve resion among vertigo patients in the emergency department
Scientific Title:Acronym
To establish detecting central vertigo
Region
| Japan |
Condition
Condition
vertigo and diziness
Classification by specialty
| Neurology | Neurosurgery | Emergency medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish detecting central nerve resion among vertigo patients in the emergency department
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain hemorrhage or brain infarction detected by head CT or MRI.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are complained with dizziness or vertigo, came to emergency room of National Center Hospital of Center of Global Health and Medicine (Tokyo, Japan), Ichinomiya Municipal Hospital, Ichinomiya City (Aichi, Japan), Yokosuka General Hospital Uwamach (Kanagawa, Japan), National Hospital Organization Kumamoto Medical Center (Kumamoto, Japan), Gifu Prefectural General Medical Center (Gifu, Japan), and Kurashiki Central Hospital (Okayama, Japan) by the ambulance.
Key exclusion criteria
Dizziness or vertigo which is caused by external reason such as trauma or toxicity, or patients who are coma at the time they come to emregency room.
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Kimura |
Organization
National Center for Global Health and Medicine, Japan
Division name
Department of Emergency Medicine and Critical Care
Zip code
1628655
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
takusato@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Takunori |
| Middle name | |
| Last name | Sato |
Organization
National Center for Global Health and Medicine, Japan
Division name
Department of Emergency Medicine and Critical Care
Zip code
1628655
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
rinrijm@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine, Japan
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labour and Welfare department lab fee
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
National Center for Global Health and Medicine, Japan
Address
1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
Tel
0332027281
d-19sato@hospk.ncgm.go.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
| 2011 | Year | 01 | Month | 13 | 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
| 2010 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2010 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 10 | Day |
Other
Other related information
Compare between dizziness or vertigo cause of brain hemorrhage or brain infarction and cause of exept brain hemorrhage or brain infarction, with patients' vital signs and labo data.
Management information
Registered date
| 2011 | Year | 01 | Month | 13 | Day |
Last modified on
| 2022 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005427
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/01/20 | めまい研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/01/28 | diz_whole data.xlsx |
