UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045598 |
|---|---|
| Receipt number | R000052061 |
| Scientific Title | Identification of Blood Biomarkers Associated with Cardiac Remodeling after Myocardial Infarction |
| Date of disclosure of the study information | 2021/09/29 |
| Last modified on | 2021/09/29 16:04:48 |
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Basic information
Public title
Identification of Blood Biomarkers Associated with Cardiac Remodeling after Myocardial Infarction
Acronym
Identification of Blood Biomarkers Associated with Cardiac Remodeling after Myocardial Infarction
Scientific Title
Identification of Blood Biomarkers Associated with Cardiac Remodeling after Myocardial Infarction
Scientific Title:Acronym
Identification of Blood Biomarkers Associated with Cardiac Remodeling after Myocardial Infarction
Region
| Japan |
Condition
Condition
Myocardial Infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aim to identify biomarkers clinically related to cardiac remodeling after myocardial infarction by measuring biomarkers we have identified in mouse models of myocardial infarction in human myocardial infarction patients, and to develop a myocardial infarction stratification score based on these blood biomarkers and other clinical parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients who have suffered a myocardial infarction and are being treated at the study institutions will be recruited as study subjects at the time of outpatient or inpatient care. An additional 10 ml of blood will be collected for research purposes when blood samples are taken for usual medical treatment, and biomarkers will be measured (plasma proteome analysis using SomaLogic's SOMAscan or ELISA analysis of target proteins). At the same time, clinical information will be registered using the EDC system after anonymization. These specimen and information collection will be collected in the acute phase immediately before or after hospitalization, in the subacute phase before discharge, and in the chronic phase approximately six months to one year later. As a result, the primary endpoint of the study will be to validate the efficacy of blood biomarkers as predictors of myocardial remodeling after myocardial infarction.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Persons who have given written consent to participate in the research.
2. Males and females aged 20 years or older at the time of obtaining consent
3. Patients who have been diagnosed with myocardial infarction at a research participating institutions
Key exclusion criteria
1. Hemodialysis cases
2. Patients with cancer
3. Patients with blood disorders
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Seitaro |
| Middle name | |
| Last name | Nomura |
Organization
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Division name
Department of Therapeutic Strategy for Heart Failure
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
seitaro_n@msn.com
Public contact
Name of contact person
| 1st name | Seitaro |
| Middle name | |
| Last name | Nomura |
Organization
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Division name
Department of Therapeutic Strategy for Heart Failure
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
seitaro_n@msn.com
Sponsor or person
Institute
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Office for Human Research Studies, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学医学部附属病院(東京都)、国立国際医療研究センター(東京都)、聖路加国際病院(東京都)、虎の門病院(東京都)、榊原記念病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 29 | 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
| 2021 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 23 | 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
Patients who have suffered a myocardial infarction and are undergoing treatment at research participating facilities will be recruited as research subjects at the time of outpatient or inpatient admission. As soon as patients are identified as eligible research subjects, the principal investigator and sub-investigators will confirm that there are no problems with the selection and exclusion criteria and will register them as research subjects. Informed consent will be obtained from the research subjects or their substitutes prior to their participation in the research. The principal investigator or sub-investigator will obtain consent by explaining the research in terms that the research subject or alternate research subject can easily understand, using a consent explanation document approved by the Ethics Review Committee. Consideration will be given to the authority gradient when obtaining consent. Then, when blood is drawn in the clinic, an additional 10 ml of blood will be collected for the study. The plasma components will be stored in EDTA-coated tubes at -80 degree centigrade. After anonymization with a corresponding table, biomarkers will be measured (e.g., plasma proteome analysis or ELISA analysis of target proteins. The plasma proteome will be analyzed using SomaLogic's SOMAscan. At the same time, clinical information will be registered using the EDC system after anonymization. These specimens and information will be collected in the acute phase immediately before or after hospitalization, in the subacute phase before discharge, and in the chronic phase approximately six months to one year later. The obtained data will be statistically processed using methods such as Kaplan-Meier analysis, logistic regression analysis, odds ratio calculation, and ROC analysis. As a result, we aim to validate the efficacy of blood biomarkers as predictors of myocardial remodeling after myocardial infarction as the primary endpoint.
Management information
Registered date
| 2021 | Year | 09 | Month | 29 | Day |
Last modified on
| 2021 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052061
