UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010048 |
|---|---|
| Receipt number | R000011670 |
| Scientific Title | The effect of inflammation of pericardial adipose tissue on cardiac function or on adipose-derived stem cells |
| Date of disclosure of the study information | 2013/02/15 |
| Last modified on | 2021/08/22 13:22:43 |
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Basic information
Public title
The effect of inflammation of pericardial adipose tissue on cardiac function or on adipose-derived stem cells
Acronym
Is the property of adipose tissue affected by its circumstances?
Scientific Title
The effect of inflammation of pericardial adipose tissue on cardiac function or on adipose-derived stem cells
Scientific Title:Acronym
Is the property of adipose tissue affected by its circumstances?
Region
| Japan |
Condition
Condition
cardiac surgery in the adults
Classification by specialty
| Cardiology | Surgery in general | Cardiovascular surgery |
| Plastic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of pericardial adipose tissue on the cardiac muscle, endothelial cells or adipose-derived stem cells
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Does inflammation of the adipose tissues depend on the distance from the organ?
Key secondary outcomes
Relationship between adipose tissue and serum fat
Relationship between inflammation of the pericardial adipose and arterial fibrillation
Relationship between the change of 24-hours serum glucose and adipose tissue?
The functional assessment of adipose-derived stem cells provided from different parts of the body.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
tissue collection (adipose and cardiac muscle)
Blood Collection
24-hours glucose measurement
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
Adult patients who undergo cardiovascular surgery in our department
Key exclusion criteria
Emergency or Urgent cases who cannot be performed preoperative evaluation
Patient who has an episode of previous open chest surgery
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Matsushita |
Organization
Juntendo University, School of Medicine
Division name
Department of Cadiovascular Surgery
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
saty-m@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Matsushita |
Organization
Juntendo University, School of Medicine
Division name
Department of Cadiovascular Surgery
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
saty-m@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University, School of Medicine
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
Juntendo University, School of Medicine
Address
Hongo2-1-1, Bunkyo-ku Tokyo
Tel
03-3813-3111
saty-m@juntendo.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
| 2013 | Year | 02 | Month | 15 | 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
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 14 | Day |
Last modified on
| 2021 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011670
| 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 |
