UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040165 |
|---|---|
| Receipt number | R000045793 |
| Scientific Title | Study on the behavior of plasma microRNA145, microRNA143, progranulin and exosome |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2025/10/19 14:54:28 |
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Basic information
Public title
Study on the behavior of plasma microRNA145, microRNA143, progranulin and exosome
Acronym
Study on the behavior of plasma microRNA145, microRNA143, progranulin and exosome
Scientific Title
Study on the behavior of plasma microRNA145, microRNA143, progranulin and exosome
Scientific Title:Acronym
Study on the behavior of plasma microRNA145, microRNA143, progranulin and exosome
Region
| Japan |
Condition
Condition
cardiac patients (coronary artery disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular disease, myocardial infarction)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between plasma microRNA145, microRNA143, progranulin,
exosome and cardiac function
Basic objectives2
Others
Basic objectives -Others
Effect of plasma microRNA145, microRNA143, progranulin and exosome on cardiac function in the chronic phase in patients with acute myocardial infarction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the relationship between plasma microRNA145, microRNA143, progranulin,
exosome and cardiac function
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cardiac patents (coronary artery disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, myocardial infarction)
Patients with written informed consent
Key exclusion criteria
patients judged as inappropriate by
the doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Minatoguchi |
Organization
Gifu University
Division name
Department of Circulatory and Respiratory Advanced Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu Prefecture
TEL
058-230-6523
minatos@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Minatoguchi |
Organization
Gifu University
Division name
Department of Circulatory and Respiratory Advanced Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu Prefecture
TEL
058-230-6523
Homepage URL
minatos@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Gifu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical comittee Gifu Univetsity School of Medicine
Address
1-1 Yanagido, Gifu City, Gifu Prefecture
Tel
058-230-6059
rinri@gifu-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
| 2022 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
doi: 10.1253/circj.CJ-22-0698
Publication of results
Partially published
Result
URL related to results and publications
doi: 10.1253/circj.CJ-22-0698
Number of participants that the trial has enrolled
45
Results
The increase in plasma miR-143 concentrations in the acute phase was positively correlated with the increase in LVEF in the chronic phase. Among many factors, only the increase in miR-143 was favorably correlated with left ventricle (LV) functional recovery in the chronic phase
Results date posted
| 2025 | Year | 10 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 11 | Month | 01 | Day |
Baseline Characteristics
The increase in plasma miR-143 concentrations in 　the acute phase was positively correlated with the increase in LVEF in the chronic phase. Among many factors, only the increase in miR-143 was favorably correlated with left ventricle (LV) functional recovery in the chronic phase
Participant flow
he increase in plasma miR-143 concentrations in the acute phase was positively correlated with the increase in LVEF in the chronic phase. Among many factors, only the increase in miR-143 was favorably correlated with left ventricle (LV) functional recovery in the chronic phase
Adverse events
non
Outcome measures
plasma miR-143 concentration, left ventricular ejection fraction
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We aim to clarify the relationship between plasma microRNA145, microRNA143, progranulin, exosome and cardiac function in cardiac patients.
Management information
Registered date
| 2020 | Year | 04 | Month | 15 | Day |
Last modified on
| 2025 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045793
