UMIN-CTR Clinical Trial

Basic information
Public title	Study of the relationship between atrial myocardium and periatrial tissue
Acronym	Study of the relationship between atrial myocardium and periatrial tissue
Scientific Title	Study of the relationship between atrial myocardium and periatrial tissue
Scientific Title:Acronym	Study of the relationship between atrial myocardium and periatrial tissue
Region	Japan

Condition
Condition	atrial fibrillation, arrhythmia
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the relationship between atrial myocardium and periatrial tissue
Basic objectives2	Others
Basic objectives -Others	To elucidate the relationship between periatrial tissue and various proteins
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To elucidate yhe relationship between atrial myocardium and periatrial tissue
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who receive cardiovascular surgery in our hospital. Patients not youger than 20 years old (at the time of informed consent) Genders do not matter. Patients providing written informed consent with their own will.
Key exclusion criteria	Patints who do not have consent ability. Patients who were judged to be inappropriate for this study.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Naohiko Middle name Last name Takahashi
Organization	Faculty of Medicine, Oita University
Division name	Department of Cardiology and Clinical Examination
Zip code	879-5593
Address	1-1, Idaigaoka, Hasamamachi, Yufu, Oita
TEL	097-586-5974
Email	takanao@oita-u.ac.jp

Public contact
Name of contact person	1st name Ichitaro Middle name Last name Abe
Organization	Faculty of Medicine, Oita University
Division name	Department of Cardiology and Clinical Examination
Zip code	879-5593
Address	1-1, Idaigaoka, Hasamamachi, Yufu, Oita
TEL	097-586-5974
Homepage URL
Email	i-taro@oita-u.ac.jp

Sponsor
Institute	Department of Cardiology and Clinical Examination, Faculty of Medicine, Oita University
Institute
Department

Funding Source
Organization	Department of Cardiology and Clinical Examination, Faculty of Medicine, Oita 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	Oita University IRB
Address	1-1 idaigaoka yufu
Tel	0975494411
Email	syomu@oita-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 02 Month 14 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	2014 Year 11 Month 27 Day
Date of IRB	2017 Year 08 Month 14 Day
Anticipated trial start date	2015 Year 01 Month 01 Day
Last follow-up date	2040 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Not particular

Management information
Registered date	2017 Year 02 Month 14 Day
Last modified on	2020 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030027