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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002020
Receipt No. R000002464
Scientific Title Specificity of plasma sLOX-1 in emergency patients
Date of disclosure of the study information 2009/05/30
Last modified on 2010/05/25

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Basic information
Public title Specificity of plasma sLOX-1 in emergency patients
Acronym Specificity of sLOX-1
Scientific Title Specificity of plasma sLOX-1 in emergency patients
Scientific Title:Acronym Specificity of sLOX-1
Region
Japan

Condition
Condition Chest pain (Acute coronary syndrome and others)
Classification by specialty
Cardiology Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the diagnostic availability of plasma sLOX-1 for ST elevation acute myocardial infarction (STEMI)
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes high value of plasma sLOX-1 in patients with STEMI
Key secondary outcomes not high valeu of plasma sLOX-1 in patients without STEMI

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria within 24 hours from the onset of chest pain
Key exclusion criteria none
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noritake Hata
Organization Chiba Hokusoh Hospital, Nippon Medical School
Division name ICU
Zip code
Address 1715 Kamagari, Inbamura, Chiba, Japan
TEL 0476-99-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noritake Hata
Organization Chiba Hokusoh Hospital, Nippon Medical School
Division name ICU
Zip code
Address 1715 Kamagari, Inbamura, Chiba, Japan
TEL 0476-99-1111
Homepage URL
Email hata-n@nms.ac.jp

Sponsor
Institute ICU, Chiba Hokusoh Hospital, Nippon Medical School
Institute
Department

Funding Source
Organization Shionogi Pharmetheutics
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kyoto University
Name of secondary funder(s) Shionogi Pharmetheutics

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 05 Month 30 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 Completed
Date of protocol fixation
2009 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2009 Year 10 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2010 Year 01 Month 01 Day

Other
Other related information no information now

Management information
Registered date
2009 Year 05 Month 30 Day
Last modified on
2010 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002464

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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