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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013673
Receipt No. R000015960
Scientific Title Study on factors related to early atrial fibrillation following cardiac surgery -the influence of epicardial adipose tissue-
Date of disclosure of the study information 2015/04/08
Last modified on 2019/01/08

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Basic information
Public title Study on factors related to early atrial fibrillation following cardiac surgery -the influence of epicardial adipose tissue-
Acronym Study on factors related to early atrial fibrillation following cardiac surgery
Scientific Title Study on factors related to early atrial fibrillation following cardiac surgery -the influence of epicardial adipose tissue-
Scientific Title:Acronym Study on factors related to early atrial fibrillation following cardiac surgery
Region
Japan

Condition
Condition Patients undergoing cardiac surgery with cardiopulmonary bypass
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Searching for the factors of post operative atrial fibrillation analyzed with relationships among epicardial adipose tissue, inflammation, cytokine and fibrosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Occurrence of post operative atrial fibrillation
Key secondary outcomes patients' characteristics, transthoracic echocardiography, Carto CT(left atrium volume, epicardial adipose tissue volume), Holter ECG, inflammation marker, fibrotic marker, fluid balance, hemodynamics

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 Patients undergoing cardiovascular surgery with cardiopulmonary bypass
Key exclusion criteria thyroid disease
inflammatory disease
malignancy
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yaoita Hiroko
Organization Nihon University Itabashi hospital
Division name Cardiac Surgery
Zip code
Address 30-1Oyaguchikami-cho, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Email yaoita.h@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yaoita Hiroko
Organization Nihon University Itabashi hospital
Division name Cardiac Surgery
Zip code
Address 30-1Oyaguchikami-cho, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Homepage URL
Email yaoita.h@gmail.com

Sponsor
Institute Nihon University Itabashi hospital Cardiac Surgery
Institute
Department

Funding Source
Organization Nihon University Itabashi hospital Cardiac Surgery
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
2015 Year 04 Month 08 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
2014 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information see article

Management information
Registered date
2014 Year 04 Month 08 Day
Last modified on
2019 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015960

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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