UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039763 |
|---|---|
| Receipt number | R000045352 |
| Scientific Title | Nationwide Fulminant Myocarditis Registry in Japan |
| Date of disclosure of the study information | 2020/03/16 |
| Last modified on | 2023/10/19 22:31:44 |
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Basic information
Public title
Nationwide Fulminant Myocarditis Registry in Japan
Acronym
Fulminant Myocarditis Registry
Scientific Title
Nationwide Fulminant Myocarditis Registry in Japan
Scientific Title:Acronym
Fulminant Myocarditis Registry
Region
| Japan |
Condition
Condition
Fulminant myocarditis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the prognosis, and invest the associated factors for short and long-term prognosis of fulminant myocarditis.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1. In-hospital death
2. long-term prognosis
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Myocarditis underwent inotropes, IABP, V-A ECMO, or heart transplant during hospitalization.
Key exclusion criteria
Cardiac sarcoidosis
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Onoue |
Organization
Nara Medical University
Division name
Department of Cardiovascular Medicine
Zip code
634-8522
Address
Shijo-cho 840, Kashihara City, Nara Prefecture
TEL
0744-22-3051
konoue@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Koshiro |
| Middle name | |
| Last name | Kanaoka |
Organization
Nara Medical University
Division name
Department of Cardiovascular Medicine
Zip code
634-8522
Address
Shijo-cho 840, Kashihara City, Nara Prefecture
TEL
0744-22-3051
Homepage URL
kanaokak@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical 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
Nara Medical University Ethics Committee
Address
Shijo-cho 840, Kashihara City, Nara Prefecture
Tel
0744-22-3051
ino_rinri@naramed-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
| 2020 | Year | 03 | Month | 16 | Day |
Related information
URL releasing protocol
doi: 10.1161/CIRCULATIONAHA.121.058869.
Publication of results
Published
Result
URL related to results and publications
doi: 10.1161/CIRCULATIONAHA.121.058869.
Number of participants that the trial has enrolled
819
Results
This study included 344 patients with histologically proven fulminant myocarditis. The cumulative risk of death or heart transplantation at 90 days was 29%.
Results date posted
| 2023 | Year | 10 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 09 | Month | 27 | Day |
Baseline Characteristics
The median age was 54 years and 40% were female.
Participant flow
This study included 344 patients with histologically proven fulminant myocarditis.
Adverse events
NA
Outcome measures
The cumulative risk of death or heart transplantation at 90 days was 29%.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort study
Management information
Registered date
| 2020 | Year | 03 | Month | 11 | Day |
Last modified on
| 2023 | 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=R000045352
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
