UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058309 |
|---|---|
| Receipt number | R000066487 |
| Scientific Title | Characteristics and predictors of fulminant progression in patients with acute myocarditis |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/06/28 21:40:58 |
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Basic information
Public title
Characteristics and predictors of fulminant progression in patients with acute myocarditis (REACTION study)
Acronym
Characteristics and predictors of fulminant progression in patients with acute myocarditis
Scientific Title
Characteristics and predictors of fulminant progression in patients with acute myocarditis
Scientific Title:Acronym
REACTION study
Region
| Japan |
Condition
Condition
acute myocarditis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the predictors of fulminant progression in patients with acute myocarditis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fulminant progression (requiring mechanical circulatory support)
Key secondary outcomes
In-hospital death, heart transplantation, or left ventricular assist device implantation.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients hospitalized with a diagnosis of acute myocarditis.
Key exclusion criteria
Cases that do not meet the guideline-based diagnostic criteria for acute myocarditis
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Suzuki |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
3908621
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
+81263373486
jersey0042@gmail.com
Public contact
Name of contact person
| 1st name | Takenori |
| Middle name | |
| Last name | Aoki |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
3908621
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
+81263373486
Homepage URL
aoki_takenori@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
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
Shinshu University Institutional Review Board
Address
3-1-1,Asahi,Matsumoto,Nagano
Tel
+81263372572
mdrinri@shinshu-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 | 08 | 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 | 05 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2025 | Year | 06 | Month | 28 | Day |
Last modified on
| 2025 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066487
