UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020744 |
|---|---|
| Receipt number | R000023941 |
| Scientific Title | Construction of the medical information system which aims education and total life care for patients with congenital heart diseases. |
| Date of disclosure of the study information | 2016/01/27 |
| Last modified on | 2020/08/20 19:41:07 |
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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 | Obstetrics 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
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
chishaki@hs.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Graduate School of Medical Sciences
Department of Health Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023941
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
