UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043306 |
|---|---|
| Receipt number | 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 | 2021/08/08 22:45:57 |
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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
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
yooouyou@gmail.com
Sponsor or person
Institute
Mitsui Memorial 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
Ethics Committee in Mitsui Memorial Hospital
Address
1 KandaIzumi-cyo, Chiyoda-ku, Tokyo
Tel
+81338629236
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
Terminated
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 | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049391
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
