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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007614
Receipt No. R000008977
Scientific Title Multi center registry of Acute Myocardial Infarction (AMI) for survey in time delay factors from onset
Date of disclosure of the study information 2012/03/31
Last modified on 2013/10/30

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Basic information
Public title Multi center registry of Acute Myocardial Infarction (AMI) for survey in time delay factors from onset
Acronym J-PULSE-AMI-Delay
Scientific Title Multi center registry of Acute Myocardial Infarction (AMI) for survey in time delay factors from onset
Scientific Title:Acronym J-PULSE-AMI-Delay
Region
Japan

Condition
Condition Acute Myocardial Infarction (AMI)
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study objective is to investigate factors of time delay from onset to reperfusion therapy in hospital for AMI patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Survival at discharge
Key secondary outcomes 1)Survival at 30 days
2)Length of hospital stay

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 AMI admission patients within 24 hours from onset
Key exclusion criteria Out of hospital cardiac arrest
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Nonogi
Organization Shizuoka General Hospital
Division name Hospital deputy
Zip code
Address 4-27-1, Kitaando, Aoi, Shizuoka, Shizuoka
TEL 054-247-6111
Email nonogijpulse@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Yokoyama
Organization National Cerebral and Cardiovascular Center
Division name Division of Cardiovascular Care Unit
Zip code
Address 5-7-1 Fujishirodai, Suita, Osaka
TEL 06-6833-5012
Homepage URL http://j-pulse.umin.jp/
Email hiyokoyama@hsp.ncvc.go.jp

Sponsor
Institute J-PULSE investigators
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 国立循環器病研究センター,弘前大学大学院,札幌医科大学医学部,帝京大学医学部,獨協医科大学病院,日本大学医学部駿河台日本大学病院,横浜市立大学附属市民総合医療センター,榊原記念病院,国立病院機構熊本医療センター,熊本大学大学院,小倉記念病院,神戸市立医療センター中央市民病院

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 31 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
2011 Year 11 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 10 Month 30 Day
Date trial data considered complete
2013 Year 10 Month 30 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information Age, Sex, Time points and clincal characteristics from onset, Outcomes

Management information
Registered date
2012 Year 03 Month 30 Day
Last modified on
2013 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008977

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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