UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030253 |
|---|---|
| Receipt number | R000034551 |
| Scientific Title | the observational study for the predictors of out-of-hospital ventricular fibrillation in patients with acute myocardial infarction |
| Date of disclosure of the study information | 2017/12/04 |
| Last modified on | 2019/06/01 20:59:27 |
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Basic information
Public title
the observational study for the predictors of out-of-hospital ventricular fibrillation in patients with acute myocardial infarction
Acronym
Vf-AMI study
Scientific Title
the observational study for the predictors of out-of-hospital ventricular fibrillation in patients with acute myocardial infarction
Scientific Title:Acronym
Vf-AMI study
Region
| Japan |
Condition
Condition
out-of-hospital ventricular fibrillation, acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate anatomical predictors for out-of-hospital ventricular fibrillation in patients with acute myocardial infarction
Basic objectives2
Others
Basic objectives -Others
short-term mortality
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
anatomical predictors for out-of-hospital ventricular fibrillation in patients with acute myocardial infarction
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients over 20 years-old
patients with diagnosis of type 1 AMI defined as Third Universal Definition of Myocardial Infarction
Key exclusion criteria
patients who reject to participate
patients without performing CAG
patients with diagnosis of not type 1 AMI defined as Third Universal Definition of Myocardial Infarction
Target sample size
326
Research contact person
Name of lead principal investigator
| 1st name | Toshiro |
| Middle name | |
| Last name | Shinke |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe 6500017, Japan
TEL
078-382-5846
shinke@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoichiro |
| Middle name | |
| Last name | Sugizaki |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe 6500017, Japan
TEL
078-382-5846
Homepage URL
catheg@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
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
Kobe university hospital clinical research centor
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe 6500017, Japan
Tel
078-382-6669
kansatsu@med.kobe-u.ac.jp
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
| 2017 | Year | 12 | Month | 04 | Day |
Related information
URL releasing protocol
https://doi.org/10.1007/s00380-018-1225-2
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s00380-018-1225-2
Number of participants that the trial has enrolled
311
Results
Multivariate logistic regression analysis identified the culprit lesion located in the proximal LCA [odds ratio (OR) 2.86; 95% confidence interval (CI) 1.34 6.08], the presence of CTO (OR 8.52; 95% CI 3.35 21.65), and MVD (OR 3.69; 95% CI 1.57 8.65) as predictors of out-of-hospital VF.
Results date posted
| 2019 | Year | 06 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
ACS patients
Participant flow
retrospective
Adverse events
None
Outcome measures
CAG findings
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 27 | Day |
Other
Other related information
This study finished.
Management information
Registered date
| 2017 | Year | 12 | Month | 04 | Day |
Last modified on
| 2019 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034551
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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