UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059150 |
|---|---|
| Receipt number | R000067513 |
| Scientific Title | CLinical charactEristics And outcomes foR acute MYOCARDITIS |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/08 12:55:03 |
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Basic information
Public title
CLinical charactEristics And outcomes foR acute MYOCARDITIS
Acronym
CLEAR-Myocarditis
Scientific Title
CLinical charactEristics And outcomes foR acute MYOCARDITIS
Scientific Title:Acronym
CLEAR-Myocarditis
Region
| Japan |
Condition
Condition
Acute myocarditis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients who were hospitalized with acute myocarditis between April 2012 and March 2023 were enrolled from institutions nationwide to establish a large-scale registry. This registry aimed to investigate the clinical characteristics and outcomes of acute myocarditis.
Basic objectives2
Others
Basic objectives -Others
Epidemiological evaluation of acute myocarditis:
Descriptive analyses of disease characteristics, treatment strategies, and outcomes according to severity, type, and etiology of myocarditis.
Longitudinal evaluation of acute myocarditis:
Investigation of temporal trends in mortality at diagnosis, treatment strategies, and the use of mechanical circulatory support (MCS).
Clinical practice of fulminant myocarditis management:
Evaluation of outcomes according to the timing and combinations of MCS initiation.
Assessment of myocarditis associated with COVID-19 infection, vaccination, autoimmune diseases, and immune checkpoint inhibitors:
Exploration of clinical characteristics, treatment approaches, and outcomes in these specific contexts.
Association between steroid/immunosuppressive therapy and outcomes:
Investigation of prognosis according to the use and treatment strategies of these agents
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-cause death
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study population consists of patients aged 15 years or older who were hospitalized and treated in Japan between April 2012 and March 2023. As a secondary investigation of the JROAD database, patients will be identified if they have a diagnosis of acute myocarditis (ICD codes I40, I41, I423) recorded as the principal diagnosis under the Diagnosis Procedure Combination (DPC) system, the admission-precipitating diagnosis, or the first or second most resource-consuming diagnosis. Additional detailed data will be collected from each participating institution.
Key exclusion criteria
Not specifically defined.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Toyoaki |
| Middle name | |
| Last name | Murohara |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2147
kondo.toru.v2@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Kondo |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2147
Homepage URL
kondo.toru.v2@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-741-2111
ethics@med.nagoya-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
| 2025 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | 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
Epidemiological evaluation of acute myocarditis:
Descriptive analyses of disease characteristics, treatment strategies, and outcomes according to severity, type, and etiology of myocarditis.
Longitudinal evaluation of acute myocarditis:
Investigation of temporal trends in mortality at diagnosis, treatment strategies, and the use of mechanical circulatory support (MCS).
Clinical practice of fulminant myocarditis management:
Evaluation of outcomes according to the timing and combinations of MCS initiation.
Assessment of myocarditis associated with COVID-19 infection, vaccination, autoimmune diseases, and immune checkpoint inhibitors:
Exploration of clinical characteristics, treatment approaches, and outcomes in these specific contexts.
Association between steroid/immunosuppressive therapy and outcomes:
Investigation of prognosis according to the use and treatment strategies of these agents.
Management information
Registered date
| 2025 | Year | 09 | Month | 21 | Day |
Last modified on
| 2025 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067513
