UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046748 |
|---|---|
| Receipt number | R000053335 |
| Scientific Title | Transcriptome study using recovered vascular endothelial cells from cardiac bypass surgery graft fragments. |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2022/03/29 12:58:59 |
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Basic information
Public title
Transcriptome study using recovered vascular endothelial cells from cardiac bypass surgery graft fragments.
Acronym
Transcriptome study using recovered vascular endothelial cells from cardiac bypass surgery graft fragments.
Scientific Title
Transcriptome study using recovered vascular endothelial cells from cardiac bypass surgery graft fragments.
Scientific Title:Acronym
Transcriptome study using recovered vascular endothelial cells from cardiac bypass surgery graft fragments.
Region
| Japan |
Condition
Condition
Patients undergoing coronary bypass surgery
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The first step is to establish an experimental system to extract fresh vascular endothelial cells by sorting and detect mRNA.
Basic objectives2
Others
Basic objectives -Others
Second, fresh endothelial cells will be harvested from excess graft fragments discarded during cardiac bypass surgery (preferably forearm artery grafts) using the same technique as for catheters and compared to see if mRNA analysis yields the same results.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Establishing the test
Key secondary outcomes
Equivalence of mRNA expression (vascular endothelial cells from bypasses, catheters), and mRNA analysis will investigate the expression levels of intrinsic markers that prove that the cells are vascular endothelial cells, as well as target molecules that are elevated in atherosclerosis (vascular adhesion factor, metabolism, calcification, inflammation, eNOS, etc.).
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing heart bypass surgery
Key exclusion criteria
None
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Masaki |
Organization
National Defense Medical College
Division name
Intensive Care Medicine
Zip code
359-8513
Address
3-2 Namiki, Tokorozawa
TEL
+81429951211
masakinobuyuki@hotmail.com
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Masaki |
Organization
National Defense Medical College
Division name
Intensive Care Medicine
Zip code
359-8513
Address
3-2 Namiki, Tokorozawa
TEL
+81429951211
Homepage URL
masakinobuyuki@hotmail.com
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College,Intensive Care Medicine
Address
3-2 Namiki, Tokorozawa, Japan
Tel
+81429951211
masakinobuyuki@hotmail.com
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
| 2022 | Year | 02 | Month | 01 | 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
| 2022 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, there is no invasion of cell collection; the only invasion is blood collection.
Management information
Registered date
| 2022 | Year | 01 | Month | 27 | Day |
Last modified on
| 2022 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053335
