UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047579 |
|---|---|
| Receipt number | R000054257 |
| Scientific Title | Cardiac MRI findings of repaired tetralogy of Fallot: A meta-analysis |
| Date of disclosure of the study information | 2022/04/25 |
| Last modified on | 2023/11/29 09:42:54 |
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Basic information
Public title
Cardiac MRI findings of repaired tetralogy of Fallot: A meta-analysis
Acronym
Cardiac MRI findings of repaired tetralogy of Fallot: A meta-analysis
Scientific Title
Cardiac MRI findings of repaired tetralogy of Fallot: A meta-analysis
Scientific Title:Acronym
Cardiac MRI findings of repaired tetralogy of Fallot: A meta-analysis
Region
| Japan |
Condition
Condition
repaired tetralogy of Fallot
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although the cardiac MRI finding of repaired TOF (rTOF) has been reported in previous studies, these findings' prevalence and clinical relevance are unclear. This meta-analysis will clarify the prevalence and prognostic value of CMR findings for patients with rTOF.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of abnormalities of CMR findings and impact on the prognosis in patients with rTOF.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
repaired TOF
Key exclusion criteria
N/A
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Yokohama City University
Division name
Department of Diagnostic Radiology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawaku, Yokohama, Japan
TEL
07026335766
shingo.m12226@gmail.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Yokohama City University Hospital
Division name
Department of Diagnostic Radiology
Zip code
236-0004
Address
Fukuura, Kanazawaku
TEL
07026335766
Homepage URL
shingo.m12226@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
None
Address
None
Tel
None
None
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
| 2022 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
DOI: 10.1007/s00380-023-02332-y
Publication of results
Published
Result
URL related to results and publications
DOI: 10.1007/s00380-023-02332-y
Number of participants that the trial has enrolled
856
Results
Our meta-analysis showed a significant increase in LV-ECV among rTOF patients compared to control subjects (MD = 2.63, 95%CI: 1.35 to 3.90, p < 0.0001, I2 = 86%, p for heterogeneity < 0.00001). Moreover, RV-ECV was found to be substantially higher in patients compared to LV-ECV. Our meta-analysis also revealed a significant association between RV-ECV and adverse events (HR = 1.15, 95% CI: 1.04 to 1.27, p = 0.005, I2 = 0%, p for heterogeneity = 0.62).
Results date posted
| 2023 | Year | 11 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Not applicable for meta-analysis
Participant flow
Not applicable for meta-analysis
Adverse events
Not applicable for meta-analysis
Outcome measures
Not applicable for meta-analysis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This meta-analysis will extract the prevalence of abnormalities in extracellular volume fraction (ECV) or right ventricular dysfunction in patients with rTOF. In addition, we will integrate the hazard ratio of these findings for predicting adverse events.
Management information
Registered date
| 2022 | Year | 04 | Month | 24 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054257
