UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026935 |
|---|---|
| Receipt number | R000030892 |
| Scientific Title | outcome of fetal cardiomyopathies in Japan |
| Date of disclosure of the study information | 2017/04/11 |
| Last modified on | 2021/10/14 19:20:09 |
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Basic information
Public title
outcome of fetal cardiomyopathies in Japan
Acronym
outcome of fetal cardiomyopathies
Scientific Title
outcome of fetal cardiomyopathies in Japan
Scientific Title:Acronym
outcome of fetal cardiomyopathies
Region
| Japan |
Condition
Condition
fetal cardiomyopathy
Classification by specialty
| Cardiology | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess initial manifestations and clinical outcome of fetal cardiomyopathies
Basic objectives2
Others
Basic objectives -Others
clinical outcome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 years after birth
fetal demise/ neonatal death/ servive
Key secondary outcomes
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
fetal cardiomyopathy
Key exclusion criteria
bradyarrthythmia due to positive SSA antibody
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Hirono |
Organization
Toyama University
Division name
pediatrics
Zip code
9300194
Address
2630, sugitani, toyama, toyama
TEL
076-434-7313
khirono1973@gmail.com
Public contact
Name of contact person
| 1st name | sayaka |
| Middle name | |
| Last name | ozawa |
Organization
Toyama university
Division name
pediatrics
Zip code
930-0194
Address
2630, sugitani, toyama,toyama
TEL
076-434-7313
Homepage URL
sozawa34@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama university, pediatrics
Institute
Department
Personal name
Funding Source
Organization
japan society for the promoton of science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Toyama
Address
2630sugitani, toyama, toyama
Tel
076-434-2281
sozawa34@med.u-toyama.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
富山大学（富山県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
38
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
Main results already published
Date of protocol fixation
| 2017 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
the purpose of study is to determine the initial presentation echo data and outcome
of fetal cardiomyopathies
Management information
Registered date
| 2017 | Year | 04 | Month | 10 | Day |
Last modified on
| 2021 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030892
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
