UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056809 |
|---|---|
| Receipt number | R000064928 |
| Scientific Title | Postoperative mortality and risk factors in adults with congenital heart disease undergoing cardiac surgery: Insights from the Japanese registry data |
| Date of disclosure of the study information | 2025/01/24 |
| Last modified on | 2025/01/24 16:02:21 |
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Basic information
Public title
Postoperative mortality and risk factors in adults with congenital heart disease undergoing cardiac surgery: Insights from the Japanese registry data
Acronym
Postoperative mortality and risk factors from the adults with congenital heart diseases registry
Scientific Title
Postoperative mortality and risk factors in adults with congenital heart disease undergoing cardiac surgery: Insights from the Japanese registry data
Scientific Title:Acronym
Postoperative mortality and risk factors in adults with congenital heart disease undergoing cardiac surgery
Region
| Japan |
Condition
Condition
ACHD patients undergoing cardiac surgery
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate clinical outcomes and risk factors following cardiac surgery.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
In-hospital mortality
Key secondary outcomes
Length of hospital and ICU stay
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
Adults with congenital heart diseases who underwent cardiac surgery
Key exclusion criteria
Patients aged under 15 years, those who did not undergo cardiac surgery, those not classified according to the study' s ACHD complexity criteria, those with normal variants, and those with insufficient data
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Ishizu |
Organization
University of Tsukuba
Division name
Department of Cardiology, Institute of Medicine
Zip code
305-8575
Address
029-853-7668
TEL
029-853-7668
tomoco@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Osawa |
Organization
University of Tsukuba
Division name
Department of Cardiology, Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-7668
Homepage URL
tosawa49710@gmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Faculty of Medicine, University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
Tel
029-853-3022
sien.ningenss@un.tsukuba.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 24 | 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
7000
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
Main results already published
Date of protocol fixation
| 2023 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 01 | Month | 24 | Day |
Last modified on
| 2025 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064928
