UMIN-CTR Clinical Trial

Basic information
Public title	Construction of the medical information system which aims education and total life care for patients with congenital heart diseases.
Acronym	The study on managements for patients with congenital heart diseases.
Scientific Title	Construction of the medical information system which aims education and total life care for patients with congenital heart diseases.
Scientific Title:Acronym	The study on managements for patients with congenital heart diseases.
Region	Japan

Condition
Condition	Patients with adult congenital heart disease
Classification by specialty	Cardiology Obsterics and gynecology Pediatrics Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify problems in patients with congenital heart diseases
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationships between cardiac and obstetric events and clinical findings around perinatal period.
Key secondary outcomes	The relationships between cardiac events and clinical findings in the patients with congenital heart diseases.

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients diagnosed congenital heart diseases with or without treatment patients.
Key exclusion criteria	Patients with severe diseases except for congenital heart diseases.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Akiko Middle name Last name Chishaki
Organization	Kyushu University Graduate School of Medical Sciences
Division name	Department of Health Sciences
Zip code	8128582
Address	3-1-1,Maidashi,Higashi-ku, Fukuoka
TEL	092-642-6713
Email	chishaki@hs.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Akiko Middle name Last name Chishaki
Organization	Kyushu University Graduate School of Medical Sciences
Division name	Department of Health Sciences
Zip code	8128582
Address	3-1-1,Maidashi,Higashi-ku, Fukuoka
TEL	092-642-6713
Homepage URL
Email	chishaki@hs.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University Graduate School of Medical Sciences Department of Health Sciences
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor	Japan Community Health care Organization Kyushu Hospital/ National cerebral and cardiovascular center/ St.Luke international hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	KYUSHU UNIVERSITY Center for Clinical and Translational Research(CCTR)
Address	3-1-1,Maidashi,Higashi-ku, Fukuoka
Tel	092-642-5774
Email	tr-info@med.kyushu-u.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	九州大学病院(福岡県)/Kyushu University Hospital(Fukuoka) 独立行政法人地域医療機能推進機構九州病院(福岡県)/Japan Community Health care Organization Kyushu Hospital(Fukuoka) 国立循環器病研究センター(大阪府)/National Cerebral and Cardiovascular Center(Ohsaka) 聖路加国際病院(東京都)/St Luke's International Hospital(Tokyo)

Other administrative information
Date of disclosure of the study information	2016 Year 01 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	Completed
Date of protocol fixation	2016 Year 01 Month 27 Day
Date of IRB	2015 Year 08 Month 12 Day
Anticipated trial start date	2016 Year 01 Month 27 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Other
Other related information	retrospective cohort study subjects: All of the patients who matches the selection criteria, which was admitted to our hospital from January 2009 to August 2015.

Management information
Registered date	2016 Year 01 Month 26 Day
Last modified on	2020 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023941