UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054173 |
|---|---|
| Receipt number | R000061862 |
| Scientific Title | Translational Research for Establishing Novel Prevention and nobel procedure in Cardiovascular Disease |
| Date of disclosure of the study information | 2024/04/20 |
| Last modified on | 2024/04/17 08:23:43 |
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Basic information
Public title
Translational Research for Establishing Novel Prevention and nobel procedure in Cardiovascular Disease
Acronym
EHIME-CVS
Scientific Title
Translational Research for Establishing Novel Prevention and nobel procedure in Cardiovascular Disease
Scientific Title:Acronym
EHIME-CVS
Region
| Japan |
Condition
Condition
Coronary artery lesions, valvular disease, aortic dissection (aortic wall), aortic aneurysm, aortic root dilatation, peripheral artery disease, Varicose veins
Classification by specialty
| Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The pathogenesis and pathophysiology of many cardiovascular diseases are not well understood, and there is still no curative drug therapy. Therefore, it is necessary to analyze surgically harvested tissues in detail to elucidate the pathogenesis and understand the pathophysiology of diseases based on molecular, cellular, and tissue data. In this study, we aim to identify new drug targets for understanding the pathogenesis of cardiovascular diseases by analyzing surgical specimens obtained from surgical treatment of cardiovascular diseases in detail at the molecular, cellular, and tissue levels.
Basic objectives2
Others
Basic objectives -Others
Establishment of novel treatment methods
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathological tests are performed on diseased and relatively unaffected tissues to identify therapeutic target factors by detailed analysis at the molecular, cellular, and tissue levels, and by comparative analysis of the composition of the two. Specifically, proteins and metabolic molecules are characterized using mass spectrometry, nucleic acids (called RNA) are characterized using sequencers, cells are characterized using temporary incubators, and tissues are characterized using special stains and immunohistochemical stains.
In addition, imaging studies are used to evaluate preoperative and postoperative disease
Key secondary outcomes
Blood tests, patient subjective assessment
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
| 1 | years-old | <= |
Age-upper limit
| 150 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A person who performs surgical treatment in cardiovascular surgery
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hironori |
| Middle name | |
| Last name | Izutani |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Cardiovascular and Thoracic Surgery
Zip code
7910204
Address
Shitsugawa, Toon-shi, EHIME, Japan
TEL
0899605331
shinkoge@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Hironori |
| Middle name | |
| Last name | Izutani |
Organization
Ehime University Graduate School of Medicine
Division name
Ehime University Graduate School of Medicine
Zip code
7910204
Address
Shitsugawa, Toon-shi, EHIME, 791-0295, JAPAN
TEL
0899605331
Homepage URL
shinkoge@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ehime University Hospital
Address
Shitsugawa, Toon-shi, EHIME, 791-0295, JAPAN
Tel
089-960-5331
shinkoge@m.ehime-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
| 2024 | Year | 04 | Month | 20 | 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
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | 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
| 2024 | Year | 04 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061862
| Research Plan | |
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| 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 |
