UMIN-CTR Clinical Trial

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
Email	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
Email	seitaro_n@msn.com

Sponsor
Institute	Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052061