UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013738 |
|---|---|
| Receipt number | R000016017 |
| Scientific Title | Multicenter cohort study for Investigating Dystophinopathy-associated CArdiovascuLar Failure in Japan |
| Date of disclosure of the study information | 2014/04/17 |
| Last modified on | 2023/01/25 23:37:51 |
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Basic information
Public title
Multicenter cohort study for Investigating Dystophinopathy-associated CArdiovascuLar Failure in Japan
Acronym
MIDCALF-J
Scientific Title
Multicenter cohort study for Investigating Dystophinopathy-associated CArdiovascuLar Failure in Japan
Scientific Title:Acronym
MIDCALF-J
Region
| Japan |
Condition
Condition
Muscular dystrophy
Classification by specialty
| Cardiology | Neurology | Pediatrics |
| Laboratory medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Objectives of this study are 1) to investigate prevalence, clinical outcomes, and the efficacy of treatments for cardiovascular dysfunction in patients with muscular dystrophy, and 2) to investigate the utility of new imaging technologies such as speckle tracking strain imaging for diagnosing heart failure in the early stage of the disease.
Basic objectives2
Others
Basic objectives -Others
Cohort study
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence, death, heart failure, arrhythmia, thromboembolism, hospitalization, speckle tracking strain imaging, cardiac enzymes and markers.
Key secondary outcomes
Renal failure, stroke, activities of daily life, quality of life.
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 with muscular dystrophy.
Key exclusion criteria
Patients without definitive diagnosis. Patients' refusal to participate.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | KIMURA |
Organization
The University of Tokyo
Division name
Department of Cardiovascular Medicine / The Institute of Medical Science
Zip code
1088639
Address
4-6-1, Shirokanedai, Minatoku, Tokyo
TEL
03-3443-8111
esk63970-kimurakut@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | KIMURA |
Organization
The University of Tokyo
Division name
Graduate School of Medicine / The Institute of Medical Science
Zip code
1088639
Address
4-6-1, Shirokanedai, Minatoku, Tokyo
TEL
03-3443-8111
Homepage URL
esk63970-kimurakut@yahoo.co.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Koichi KIMURA
Funding Source
Organization
JSPS KAKENHI etc.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization (NHO) Hakone National Hospital; NHO Niigata National Hospital; NHO Shimoshizu National Hospital; NHO Sendainishitaga National Hospital; NHO Hiroshimanishi Medical Center, and NHO Iou National Hospital.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of The University of Tokyo
Address
4-6-1, Shirokanedai, Minatoku, Tokyo
Tel
03-6409-2172
ken-rin@ims.u-tokyo.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
東京大学医科学研究所附属病院・東京大学医学部附属病院（東京都）、国立病院機構箱根病院（神奈川県）、国立病院機構新潟病院（新潟県）、国立病院機構下志津病院（千葉県）、国立病院機構仙台西多賀病院（宮城県）、国立病院機構広島西医療センター（広島県）、国立病院機構医王病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2040 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational cohort study for cardiovascular dysfunction in patients with muscular dystrophy. Utility of speckle tracking strain imaging for heart failure in patients with muscular dystrophy.
Management information
Registered date
| 2014 | Year | 04 | Month | 16 | Day |
Last modified on
| 2023 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016017
| 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 |
