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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000015598
Receipt No. R000018124
Scientific Title Study of Ventricular Arrhythmia in Acute Cornary Syndrome Using 12-lead Holter Electrocardiogram
Date of disclosure of the study information 2014/11/04
Last modified on 2014/11/04

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Basic information
Public title Study of Ventricular Arrhythmia in Acute Cornary Syndrome Using 12-lead Holter Electrocardiogram
Acronym Study of Ventricular Arrhythmia in Acute Coronary Syndrome
Scientific Title Study of Ventricular Arrhythmia in Acute Cornary Syndrome Using 12-lead Holter Electrocardiogram
Scientific Title:Acronym Study of Ventricular Arrhythmia in Acute Coronary Syndrome
Region
Japan

Condition
Condition Acute Coronary Syndrome
Classification by specialty
Cardiology Cardiovascular surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate characteristic of ventricular arrhythmia in acute coronary syndrome circumstantially
Basic objectives2 Others
Basic objectives -Others Analysis of arrhythmia
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency and trend of arrhythmia
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 admission from acute coronary syndrome
Key exclusion criteria A patient who does not be consented
A patient who cannot continue this study because of complication
Target sample size 150

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tomonori Kanaeda
Organization Eastern Chiba Eedical Center
Division name Cardiovascular medicine
Zip code
Address 3-6-2, Okayamadai, Tougane-shi, Chiba
TEL 0475-50-1199
Email tkanaeda@chiba-u.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tomonori Kanaeda
Organization Eastern Chiba Eedical Center
Division name Cardiovascular medicine
Zip code
Address 3-6-2, Okayamadai, Tougane-shi, Chiba
TEL 0475-50-1199
Homepage URL
Email tkanaeda@chiba-u.jp

Sponsor
Institute Eastern Chiba Eedical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 04 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 Preinitiation
Date of protocol fixation
2014 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Before starting study

Management information
Registered date
2014 Year 11 Month 04 Day
Last modified on
2014 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018124

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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