UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007614 |
|---|---|
| Receipt number | 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 15:33:05 |
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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
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/
hiyokoyama@hsp.ncvc.go.jp
Sponsor or person
Institute
J-PULSE investigators
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
