UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023789 |
|---|---|
| Receipt number | 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 14:58:58 |
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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
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
mkubo@yamaguchi-u.ac.jp
Sponsor or person
Institute
Division of Internal Medicine 2
Yamaguchi University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027389
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
