UMIN-CTR Clinical Trial

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
Email	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
Email	ayano.yoshida.0121@gmail.com

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053036