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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010048
Receipt No. 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 2017/08/19

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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
Middle name
Last name Satoshi Matsushita
Organization Juntendo University, School of Medicine
Division name Department of Cadiovascular Surgery
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email saty-m@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Matsushita
Organization Juntendo University, School of Medicine
Division name Department of Cadiovascular Surgery
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email saty-m@juntendo.ac.jp

Sponsor
Institute Juntendo University, School of Medicine
Institute
Department

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
Address
Tel
Email

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
2017 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011670

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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