UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044765 |
|---|---|
| Receipt number | R000051129 |
| Scientific Title | Role of the mitochondrial dysfunction of human epicardial adipose tissue in the atrial remodeling |
| Date of disclosure of the study information | 2022/12/31 |
| Last modified on | 2022/10/09 13:24:00 |
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Basic information
Public title
Role of the mitochondrial dysfunction of human epicardial adipose tissue in the atrial remodeling
Acronym
EAT mitochondrial dysfunction and atrial remodeling
Scientific Title
Role of the mitochondrial dysfunction of human epicardial adipose tissue in the atrial remodeling
Scientific Title:Acronym
EAT mitochondrial dysfunction and atrial remodeling
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) To evaluate the relationship between EAT mitochondrial function and EAT volume or atrial remodeling parameters. (2) To evaluate the relationship betweeen EAT mitochondrial function and gene expression of adipocytokines. (3) To examine whether impaired EAT mitochondrial function leads to atrial histological and electrophysiological remodelings. (4) To examine what regulate the impaired EAT mitochondrial function.
Basic objectives2
Others
Basic objectives -Others
Assessment of the cause of disease progresssion
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Structural and functional remodeling of atrium
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who receives cardiac surgery
Key exclusion criteria
Severe systolid function (LVEF < 40%)
Moderate and severe valve disease (aortic and/or mitral valves)
Persistent atrial fibrillation
Emergency surgery
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Watanabe |
Organization
Hokkaido University Hospital
Division name
Department of cardiovascular medicine
Zip code
060-8648
Address
North 14, West 5, Kita-ku, Sapporo city
TEL
0117066973
m.watanabe@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | Watanabe |
| Last name | Watanabe |
Organization
Hokkaido University Hospital
Division name
Department of cardiovascular medicine
Zip code
060-8638
Address
North 14, West 5, sapporo city
TEL
0117066973
Homepage URL
masayawatanabe38@gmail.com
Sponsor or person
Institute
Department of cardiovascular medicine
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Hokkaido University
Address
North 14, West 5, sapporo city
Tel
0117066973
m.watanabe@huhp.hokudai.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
| 2022 | Year | 12 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross-sectional study
Management information
Registered date
| 2021 | Year | 07 | Month | 05 | Day |
Last modified on
| 2022 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051129
