UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046482 |
|---|---|
| Receipt number | R000053036 |
| Scientific Title | The multicenter cohort study of prognosticator in patient with acute myocarditis |
| Date of disclosure of the study information | 2021/12/27 |
| Last modified on | 2021/12/27 00:06:50 |
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Basic information
Public title
The multicenter cohort study of prognosticator in patient with acute myocarditis
Acronym
The multicenter cohort study of prognosticator in patient with acute myocarditis
Scientific Title
The multicenter cohort study of prognosticator in patient with acute myocarditis
Scientific Title:Acronym
The multicenter cohort study of prognosticator in patient with acute myocarditis
Region
| Japan |
Condition
Condition
Acute myocarditis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the predictors of in-hospital prognosis in patients with acute myocarditis, regardless of fulminant myocarditis.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
A composite of in-hospital death from any cause, heart transplantation, and the ventricular assist device implantation during the index hospitalization
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients suffering acute myocarditis who were urgently hospitalized in 9 hospitals in Japan between 2007 and 2019.
Key exclusion criteria
none
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Nobuhisa |
| Middle name | |
| Last name | Hagiwara |
Organization
Tokyo Women's Medical University
Division name
Department of Cardiology
Zip code
162-8666
Address
8-1 Kawatacho, Shinjyuku-ku, Tokyo, Japan,162-8666
TEL
0333538111
hagiwara.nobuhisa@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Ayano |
| Middle name | |
| Last name | Yoshida |
Organization
Tokyo Women's Medical University
Division name
Department of Cardiology
Zip code
162-8666
Address
8-1 Kawatacho, Shinjyuku-ku, Tokyo, Japan,162-8666
TEL
0333538111
Homepage URL
ayano.yoshida.0121@gmail.com
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's 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
Ethical review board of Tokyo Women's Medical University
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
Tel
03-3353-8111
krinri.bm@twmu.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
| 2021 | Year | 12 | Month | 27 | 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
80
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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Tokyo Women's Medical University Medical Center East
Seirei Hamamatsu General Hospital
Saiseikai Kumamoto Hospital
Ogikubo Hospital
Kosei Hospital
National Hospital Organization Yokohama Medical Center
Tokyo Women's Medical University Yachiyo Medical Center
Saiseikai Kawaguchi General Hospital
Management information
Registered date
| 2021 | Year | 12 | Month | 26 | Day |
Last modified on
| 2021 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053036
