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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022096
Receipt No. 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

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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
Obsterics 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
Email 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
Email mkimura774@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital, Department of Pediatrics
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025376

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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