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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028369
Receipt No. R000032476
Scientific Title The relation between inflammation and atrial remodeling in patients with atrial fibrillation
Date of disclosure of the study information 2017/07/25
Last modified on 2017/07/25

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Basic information
Public title The relation between inflammation and atrial remodeling in patients with atrial fibrillation
Acronym The relation between inflammation and atrial remodeling in patients with atrial fibrillation
Scientific Title The relation between inflammation and atrial remodeling in patients with atrial fibrillation
Scientific Title:Acronym The relation between inflammation and atrial remodeling in patients with atrial fibrillation
Region
Japan

Condition
Condition atrial fibrillation
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of chronic inflammationon atrial remodeling.
Basic objectives2 Others
Basic objectives -Others To clarify the relationship between inflammationon along with gut dysbiosis and atrial remodeling.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes relation between peripheral blood monocytes/lymphocytes activity along with gut microbiota and atrial remodeling such as low voltage zone.
Key secondary outcomes relation between metabolites and atrial remodeling.

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
100 years-old >=
Gender Male and Female
Key inclusion criteria The atrial fibrillation patients treat with catheter ablation in Kobe university.
Key exclusion criteria 1. rejection
2. sCr>1.5mg.dl, CRP>0.3mg/dl, chronic inflammatory disease, OMI, pregnant women, NSAIDs and steroid user
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Fukuzawa
Organization Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-5846
Email kfuku@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Fukuzawa
Organization Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-5846
Homepage URL
Email kfuku@med.kobe-u.ac.jp

Sponsor
Institute Kobe university
Institute
Department

Funding Source
Organization Kobe university
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
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
2017 Year 07 Month 25 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, we investige the gut dysbiosis and its related endotoxemia/inflammation in patients with atrial fibrillation.
Furthermore, we identify the metabolites involved in the pathogenesis of atrial fibrillation.

Management information
Registered date
2017 Year 07 Month 25 Day
Last modified on
2017 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032476

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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