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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023789
Receipt No. R000027389
Scientific Title Usefulness of cardiac contrast magnetic resonance imaging for the evaluation of myocarditis complicated with dermatomyositis/polymyositis.
Date of disclosure of the study information 2016/08/28
Last modified on 2016/08/27

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Basic information
Public title Usefulness of cardiac contrast magnetic resonance imaging for the evaluation of myocarditis complicated with dermatomyositis/polymyositis.
Acronym Usefulness of cardiac contrast MRI for myocarditis in dermatomyositis/polymyositis.
Scientific Title Usefulness of cardiac contrast magnetic resonance imaging for the evaluation of myocarditis complicated with dermatomyositis/polymyositis.
Scientific Title:Acronym Usefulness of cardiac contrast MRI for myocarditis in dermatomyositis/polymyositis.
Region
Japan

Condition
Condition dermatomyositis, polymyositis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Usefulness of cardiac contrast magnetic resonance imaging for the evaluation of myocarditis in patients with dermatomyositis/polymyositis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Abnormal findings in the myocardium in the cardiac contrast MRI
Key secondary outcomes Sensitivity and specificity of the cardiac contrast MRI of cardiomyopathy in patients with dermatomyositis/polymyositis.
Risk factor of cardiomyopathy in patients with dermatomyositis/polymyositis

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
80 years-old >
Gender Male and Female
Key inclusion criteria The diagnosis of PM or DM is based on the criteria of Bohan and Peter criteria: 1) systemic muscle weakness, 2) increased serum muscle enzyme levels, 3) electromyographic (EMG) evidence of myopathic changes, 4) typical histologic findings in muscle biopsies, and/or 5) characteristic dermatologic manifestations of DM. The diagnosis is considered definite, probable, or possible according to the number of criteria fulfilled (at least 4, 3, or 2, respectively, including the dermatologic
manifestations for diagnosis of DM), and patients with definite are included in the study.
Key exclusion criteria 1) Patients who are considered to be complicated with muscle diseases other than dermatomyositis/ polymyositis.
2) Patients with a history of other myocarditis or cadiomyopathy, such as dilated cardiomyopathy and hypertrophic cadiomyopathy.
3) Patients who have been determined to be inappropriate as a study by the principal investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Kubo
Organization Yamaguchi University Hospital
Division name Internal Medicine 2
Zip code
Address 1-1-1,MinamiKogushi,Ube City,Yamaguchi Prefecture, Japan
TEL 0836-22-2248
Email mkubo@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Kubo
Organization Yamaguchi University Hospital
Division name Internal Medicine 2
Zip code
Address 1-1-1,MinamiKogushi,Ube City,Yamaguchi Prefecture, Japan
TEL 0836-22-2248
Homepage URL
Email mkubo@yamaguchi-u.ac.jp

Sponsor
Institute Division of Internal Medicine 2
Yamaguchi University Hospital
Institute
Department

Funding Source
Organization Division of Internal Medicine 2
Yamaguchi University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 山口大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 28 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
Date of protocol fixation
2016 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 29 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information Study subjects met the criteria of Bohan and Peter, one of the dermatomyositis, polymyositis patients who do not correspond to the excluded items, and those who plan to do a cardiac-enhanced MRI examination.
Along with the cardiac-enhanced MRI examination, to determine the myocarditis using cardiac enzyme test, echocardiography, and ECG findings.
For the target patients who are complicated by myocarditis, it performs a multivariate analysis with respect to factors such as age and gender, blood myositis-specific antibody, reveal myocarditis complication risk factor of dermatomyositis, polymyositis.

Management information
Registered date
2016 Year 08 Month 27 Day
Last modified on
2016 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027389

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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