UMIN-CTR Clinical Trial

Basic information
Public title	The association between epicardial adipose tissue and cardiac biomarkers.
Acronym	MMH CCTA registry
Scientific Title	The association between epicardial adipose tissue and cardiac biomarkers.
Scientific Title:Acronym	MMH CCTA registry
Region	Japan

Condition
Condition	heart failure with preserved ejection fraction heart failure with reduced ejection fraction
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to reveal the effect of epicardial adipose tissue (EAT) on heart failure by investigating of the correlation of EAT with cardiac biomarkers, cardiac function and clinical outcomes.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Association between EAT and cardiac biomarkers in heart failure patients.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who had coronary computed tomography angiography in Mitsui Memorial hospital during observational period.
Key exclusion criteria	The patients who are found unfit to be respondent to a survey by physician-in-charge.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Hideaki Middle name Last name Nonaka
Organization	Mitsui Memorial Hospital
Division name	Division of Cardiology
Zip code	101-8643
Address	1 KandaIzumi-cyo, Chiyoda-ku, Tokyo
TEL	+81338629111
Email	nonaka54hideaki@yahoo.co.jp

Public contact
Name of contact person	1st name Yu Middle name Last name Horiuchi
Organization	Mitsui Memorial Hospital
Division name	Division of Cardiology
Zip code	101-8643
Address	1 KandaIzumi-cyo, Chiyoda-ku, Tokyo
TEL	+81338629111
Homepage URL
Email	yooouyou@gmail.com

Sponsor
Institute	Mitsui Memorial 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	Ethics Committee in Mitsui Memorial Hospital
Address	1 KandaIzumi-cyo, Chiyoda-ku, Tokyo
Tel	+81338629236
Email	c-uno@mitsuihosp.or.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	2021 Year 02 Month 12 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	2021 Year 01 Month 04 Day
Date of IRB	2021 Year 01 Month 29 Day
Anticipated trial start date	2021 Year 02 Month 15 Day
Last follow-up date	2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2021 Year 02 Month 11 Day
Last modified on	2021 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049391

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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