UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017555 |
|---|---|
| Receipt number | R000017692 |
| Scientific Title | Prospective cohort research for aortic root dilatation and non-elasticity after surgical repair in adults with Tetralogy of Fallot |
| Date of disclosure of the study information | 2015/05/14 |
| Last modified on | 2023/12/31 23:03:03 |
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Basic information
Public title
Prospective cohort research for aortic root dilatation and non-elasticity after surgical repair in adults with Tetralogy of Fallot
Acronym
TRANSIT
Scientific Title
Prospective cohort research for aortic root dilatation and non-elasticity after surgical repair in adults with Tetralogy of Fallot
Scientific Title:Acronym
TRANSIT
Region
| Japan |
Condition
Condition
Tetralogy of Fallot
Classification by specialty
| Cardiology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the pace of aortic root dilatation and incidence of aortic root dilatation in adults with Tetralogy of Fallotafter surgical repair
Basic objectives2
Others
Basic objectives -Others
To evaluate risk factors of aortic root dilatation
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The pace of aortic root dilatation
Key secondary outcomes
1) Incidence of aortic root dilatation
2) Aortic elasticity evaluated by pulse wave velocity
3) Effect of oral medication, especially angiotensin receptor blocker and angiotensin converting enzyme inhibitor
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with Tetralogy of Fallot after surgical repair under 10 years old
2) Patients aged 20 year or older at registaration
Key exclusion criteria
1) Double outlet right ventricle
2) Complicated heart diseases related to aortic dilatation: bicuspid aortic valve, coarctation of aorta, interruption of aorta
3) Complicated connective tissue diseases related to aortic dilatation: Marfan syndrome, Loeys-Dietz syndrome, and others
4) ineligibles for subjects judged by a doctor in attendance
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Miura |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of Cardiology
Zip code
183-8561
Address
2-8-29 Musashi-dai, Fuchu, Tokyo, 183-8561, Japan
TEL
042-300-5111
masaru_miura@tmhp.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Nagamine |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of Cardiology
Zip code
183-8561
Address
2-8-29 Musashi-dai, Fuchu, Tokyo, 183-8561, Japan
TEL
042-300-5111
Homepage URL
hiroki_nagamine@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Office of Metropolitan Hospital Management, Tokyo Metropolitan Goverment
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Children's Medical Center
Address
2-8-29 Musashi-dai, Fuchu, Tokyo, 183-8561, Japan
Tel
042-300-5111
sn_crsc04@tmhp.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
| 2015 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
http://transitstudy.jp/
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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2015 | Year | 05 | Month | 14 | Day |
Last modified on
| 2023 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017692
