UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study to build a new remote screening system for congenital heart disease in the fetus.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masato Kimura
Organization	Tohoku university hospital
Division name	Department of Pediatrics
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	Masato Kimura
Organization	Tohoku university hospital
Division name	Department of Pediatrics
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 03 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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