UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005533 |
|---|---|
| Receipt number | R000006561 |
| Scientific Title | association between early repolarization and the VF occurrences during AMI |
| Date of disclosure of the study information | 2011/04/29 |
| Last modified on | 2012/04/30 09:19:58 |
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Basic information
Public title
association between early repolarization and the VF occurrences during AMI
Acronym
early repolarization and the VF occurrences during AMI
Scientific Title
association between early repolarization and the VF occurrences during AMI
Scientific Title:Acronym
early repolarization and the VF occurrences during AMI
Region
| Japan |
Condition
Condition
acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluated the impact of early repolarization to the ventricular fibrillation (VF) occurrence in patients with acute myocardial infarction (AMI).
Basic objectives2
Others
Basic objectives -Others
association
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
occurrence of sustained VF within 48 hours after the onset of the AMI
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with AMI in whom 12-lead ECGs before AMI onset could be evaluated
Key exclusion criteria
Patients excluded from this study were those who experienced a prior AMI and were pregnant, and QRS complex > 120 milliseconds. Patients with the Brugada syndrome, defined as right bundlebranch block and ST-segment elevation (>0.2 mV) in precordial leads V1 to V3, without intervention or following infusion of a sodium-channel blocker, also excluded.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Aonuma |
Organization
Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name
Department of Cardiology
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3142
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazutaka Aonuma |
Organization
Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name
Department of Cardiology
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3142
Homepage URL
Sponsor or person
Institute
Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
none
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
筑波大学附属病院（茨城県），つくばメディカルセンター病院（茨城県），茨城県立中央病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2010 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 01 | Day |
Other
Other related information
retrospective study
Management information
Registered date
| 2011 | Year | 04 | Month | 29 | Day |
Last modified on
| 2012 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006561
| 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 |
