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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043306
Receipt No. R000049391
Scientific Title The association between epicardial adipose tissue and cardiac biomarkers.
Date of disclosure of the study information 2021/02/12
Last modified on 2021/02/21

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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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