UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022096 |
|---|---|
| Receipt number | R000025376 |
| Scientific Title | Study to build a new remote screening system for congenital heart disease in the fetus. |
| Date of disclosure of the study information | 2016/04/27 |
| Last modified on | 2016/05/02 06:17:27 |
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Basic information
Public title
Study to build a new remote screening system for congenital heart disease in the fetus.
Acronym
Study to build a new remote screening system for CHD in the fetus.
Scientific Title
Study to build a new remote screening system for congenital heart disease in the fetus.
Scientific Title:Acronym
Study to build a new remote screening system for CHD in the fetus.
Region
| Japan |
Condition
Condition
Congenital heart disease in the fetus
Classification by specialty
| Obstetrics and Gynecology | Pediatrics | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to prove usefulness of the remote diagnosis system for the congenital heart disease in the fetus, and build a new screening system for fetal congenital heart disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Establish the useful parameters for screening fetal congenital heart disease.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Early diagnosis of the congenital heart disease of the fetus using echocardiography
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant female with the fetus older than 22weeks of gestational age with suspected congenital heart disease. Participants must be older then 20 year-old and agree to join the study.
Key exclusion criteria
Patient with following conditions are excluded from the study. Patient who did not agree to join the study, patient of age under 20 year-old, patient who did not have ability to judge, and patient who are diagnosed not applicable to join the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Kimura |
Organization
Tohoku university hospital
Division name
Department of Pediatrics
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7287
mkimura774@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Kimura |
Organization
Tohoku university hospital
Division name
Department of Pediatrics
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7287
Homepage URL
mkimura774@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital, Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Miyata Cardiac Research Promotion Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 27 | Day |
Last modified on
| 2016 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025376
