UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043455 |
|---|---|
| Receipt number | R000049101 |
| Scientific Title | Molecular biological study to elucidate pathogenicity of epicardial adipose tissue |
| Date of disclosure of the study information | 2021/02/27 |
| Last modified on | 2023/03/01 13:38:52 |
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Basic information
Public title
Molecular biological study to elucidate pathogenicity of epicardial adipose tissue
Acronym
Molecular biological study of epicardial adipose tissue
Scientific Title
Molecular biological study to elucidate pathogenicity of epicardial adipose tissue
Scientific Title:Acronym
Molecular biological study of epicardial adipose tissue
Region
| Japan |
Condition
Condition
heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical impact of epicardial adipose tissue on coronary atherosclerosis, myocardial degeneration, and heart valve disease through molecular biological approaches
Basic objectives2
Others
Basic objectives -Others
comparative reseach
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Immunohistological characteristics and expression levels of cytokines in epicardial adipose tissue based on the classification and severity of heart diseases
(2) Clinical imaging markers related to immunohistological abnormalities and cyotokine expressions in epicardial adipose 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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients aged >= 30 years old
2) patients scheduled for elective coronary artery bypass graft surgery or cardiac valve surgery
3) patients undergoing echocardiography and cardiac catheter test within 3 months before cardiac surgery
4) patients undergoing cardiac CT and/or cardiac magnetic resonance within 3 months before cardiac surgery
5) patients who agree with informed consent
Key exclusion criteria
1) critical conditions, such as immediately after brain hemorrhage
2) acute coronary syndrome, critical heart failure, and shock status
3) pregnant or breast-feedings women
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Nakano |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Department of Cardiovascular Medicine
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
TEL
082-257-5555
nakanoy@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiro |
| Middle name | Kitagawa |
| Last name | Kitagawa |
Organization
Hiroshima University Graduate School of Biomedical and Health Sciences
Division name
Department of Cardiovascular Medicine
Zip code
734-8551
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
TEL
082-257-5555
Homepage URL
toshirok@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima 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
Clinical Research Center in Hiroshima
Address
Kasumi 1-2-3 Minami-ku, Hiroshima
Tel
082-257-1752
protocol@cimr.hiroshima-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
| 2021 | Year | 02 | Month | 27 | 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 | 12 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation study
Management information
Registered date
| 2021 | Year | 02 | Month | 27 | Day |
Last modified on
| 2023 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049101
| 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 |
