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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030253
Receipt No. 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

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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
Email 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
Email catheg@med.kobe-u.ac.jp

Sponsor
Institute Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034551

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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