UMIN-CTR Clinical Trial

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
Email	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
Email	masayawatanabe38@gmail.com

Sponsor
Institute	Department of cardiovascular medicine Hokkaido University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051129