UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of cardiac contrast magnetic resonance imaging for the evaluation of myocarditis complicated with dermatomyositis/polymyositis.
Title of the study (Brief title)	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	Makoto Kubo
Organization	Yamaguchi University Hospital
Division name	Internal Medicine 2
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	Makoto Kubo
Organization	Yamaguchi University Hospital
Division name	Internal Medicine 2
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 08 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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