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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013738
Receipt No. 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 2020/04/20

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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 The aim of the study is 1) to investigate prevalence, clinical outcomes, and the efficacy of treatment 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 350

Research contact person
Name of lead principal investigator
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
Email kimurak-int@h.u-tokyo.ac.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
Email kimurak-int@h.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

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; Niigata National Hospital; Shimoshizu National Hospital; Sendainishitaga National Hospital, and Hiroshimanishi Medical Center.
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of The University of Tokyo
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel 03-5841-0818
Email ethics@m.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 東京大学医学部附属病院(東京都)、東京大学医科学研究所(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)

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
2020 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016017

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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