UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050021 |
|---|---|
| Receipt number | R000056987 |
| Scientific Title | Long-term outcomes of anatomical repair of primary or complicated coarctation of the aorta in adults |
| Date of disclosure of the study information | 2023/01/12 |
| Last modified on | 2023/01/12 18:12:43 |
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Basic information
Public title
Long-term outcomes of anatomical repair of primary or complicated coarctation of the aorta in adults
Acronym
Long-term outcomes of anatomical repair of primary or complicated coarctation of the aorta in adults
Scientific Title
Long-term outcomes of anatomical repair of primary or complicated coarctation of the aorta in adults
Scientific Title:Acronym
Long-term outcomes of anatomical repair of primary or complicated coarctation of the aorta in adults
Region
| Japan |
Condition
Condition
Coarctation of the aorta
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated our surgical approach as well as the long-term outcomes of CoA in adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Death at last follow-up.
Key secondary outcomes
Reoperation at last follow-up.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients at the age of 18 or older who underwent primary or redo operations with anatomical repair for coarctation of the aorta at Hyogo Prefectural Amagasaki General Medical Center.
Key exclusion criteria
Patients less than 18 years old, patients who underwent extraanatomical repair, patients who could not be followed, patients who underwent Norwood type operations for single ventricle physiology.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Toshi |
| Middle name | |
| Last name | Maeda |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Cardiovascular surgery
Zip code
660-8550
Address
2-17-77, Higashi-Naniwa-cho, Amagasaki, Hyogo, Japan
TEL
+81-6-6480-7000
tmsirius825@gmail.com
Public contact
Name of contact person
| 1st name | Toshi |
| Middle name | |
| Last name | Maeda |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Cardiovascular Surgery
Zip code
660-8550
Address
2-17-77, Higashi-Naniwa-cho, Amagasaki, Hyogo, Japan
TEL
+81-6-6480-7000
Homepage URL
tmsirius825@gmail.com
Sponsor or person
Institute
Hyogo Prefectural Amagasaki General Medical Center
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
Hyogo Prefectural Amagasaki General Medical Center
Address
2-17-77, Higashi-Naniwa-cho, Amagasaki, Hyogo, Japan
Tel
+81-6-6480-7000
agmc.irb@gmail.com
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
| 2023 | Year | 01 | Month | 12 | 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
8
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The medical records of all 8 patients at the age of 18 years or older who underwent primary or redo operations for coarctation of the aorta at Hyogo prefectural Amagasaki general medical center before September 2022 were retrospectively reviewed about long-term outcomes.
Management information
Registered date
| 2023 | Year | 01 | Month | 12 | Day |
Last modified on
| 2023 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056987
| 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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