UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022882 |
|---|---|
| Receipt number | R000026355 |
| Scientific Title | Prognostic scoring indicator in evaluation of cerebral infarction in the emergency department;retrospective cohort study |
| Date of disclosure of the study information | 2016/06/25 |
| Last modified on | 2016/08/05 11:32:10 |
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Basic information
Public title
Prognostic scoring indicator in evaluation of cerebral infarction in the emergency department;retrospective cohort study
Acronym
Prognostic scoring indicator in evaluation of cerebral infarction
Scientific Title
Prognostic scoring indicator in evaluation of cerebral infarction in the emergency department;retrospective cohort study
Scientific Title:Acronym
Prognostic scoring indicator in evaluation of cerebral infarction
Region
| Japan |
Condition
Condition
cerebral infarction
Classification by specialty
| Neurology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Magnetic resonance imaging(MRI) is used for definitive diagnosis of cerebral infarction(CI). Therefore MRI is frequently performed in emergency department in daily clinical.
However it is impossible that MRI is performed all patients who is suspected CI because magnetic resonance imaging is high cost and is not installed every hospital.
There are no recommended criterion whether MRI should perform or not.
The aim of this study is to review the available scoring systems used for outcome prediction in CI patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
cerebral infarction diagnosed with MRI
Key secondary outcomes
Non
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 who was emergency room visit
Key exclusion criteria
nosocomial case
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hijikata Toshiyuki |
Organization
Itabashi Chuo Medical Center
Division name
Emergency Departoment
Zip code
Address
2-12-7 Azusawa Itabashi Tokyo Japan
TEL
03-3967-1181
th.1984.06.01@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hijikata Toshiyuki |
Organization
Itabashi chuo medical center
Division name
Emergency Department
Zip code
Address
2-12-7 Azusawa Itabashi, Tokyo, Japan
TEL
03-3967-1181
Homepage URL
th.1984.06.01@gmail.com
Sponsor or person
Institute
Itabashi Chuo Medical Center
Institute
Department
Personal name
Funding Source
Organization
Non
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
Address
Tel
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
板橋中央総合病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 15 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
The hospital records of all patients who visited emergency department from Apr. 2012 to Mar. 2015 were studied. The following factors were investigated for their prognostic value: sex, age, physical findings and vital sign at emergency room, past medical history, hematological examination,and imaging findings.
Primary outcome is definitive diagnosis of cerebral infarction by magnetic resonance imaging
Management information
Registered date
| 2016 | Year | 06 | Month | 25 | Day |
Last modified on
| 2016 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026355
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
