UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028369 |
|---|---|
| Receipt number | 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 | 2019/12/29 12:39:34 |
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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 | Koji |
| Middle name | |
| Last name | Fukuzawa |
Organization
Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
658-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5846
kfuku@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Fukuzawa |
Organization
Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
658-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5846
Homepage URL
kfuku@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university
Institute
Department
Personal name
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
Kobe University Clinical Research Ethical Committee
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
078-382-6669
chiken@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 | 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
| 2019 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032476
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
