UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000022882
Receipt No. R000026355
Official scientific title of the study 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 (Ver. 2)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Prognostic scoring indicator in evaluation of cerebral infarction in the emergency department;retrospective cohort study
Title of the study (Brief title) 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 Hijikata Toshiyuki
Organization Itabashi Chuo Medical Center
Division name Emergency Departoment
Address 2-12-7 Azusawa Itabashi Tokyo Japan
TEL 03-3967-1181
Email th.1984.06.01@gmail.com

Public contact
Name of contact person Hijikata Toshiyuki
Organization Itabashi chuo medical center
Division name Emergency Department
Address 2-12-7 Azusawa Itabashi, Tokyo, Japan
TEL 03-3967-1181
Homepage URL
Email th.1984.06.01@gmail.com

Sponsor
Institute Itabashi Chuo Medical Center
Institute
Department

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Partially published
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026355