UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050688 |
|---|---|
| Receipt number | R000057739 |
| Scientific Title | Clinical Utility of Gadolinium Enhancement Magnetic Resonance Imaging for evaluation of Cardiac Events Risk in Confirmed Sarcoidosis: A Meta-Analysis |
| Date of disclosure of the study information | 2023/03/27 |
| Last modified on | 2025/04/04 15:27:20 |
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Basic information
Public title
Clinical Utility of Gadolinium Enhancement Magnetic Resonance Imaging for evaluation of Cardiac Events Risk in Confirmed Sarcoidosis: A Meta-Analysis
Acronym
Clinical Utility of Gadolinium Enhancement Magnetic Resonance Imaging for evaluation of Cardiac Events Risk in Confirmed Sarcoidosis: A Meta-Analysis
Scientific Title
Clinical Utility of Gadolinium Enhancement Magnetic Resonance Imaging for evaluation of Cardiac Events Risk in Confirmed Sarcoidosis: A Meta-Analysis
Scientific Title:Acronym
Clinical Utility of Gadolinium Enhancement Magnetic Resonance Imaging for evaluation of Cardiac Events Risk in Confirmed Sarcoidosis: A Meta-Analysis
Region
| Japan |
Condition
Condition
Sarcoidosis
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is already known that gadolinium contrast-enhanced cardiac magnetic resonance imaging is useful in assessing the presence or absence of cardiac complications in sarcoidosis. However, the clinical usefulness of delayed contrast in confirmed or suspected cardiac sarcoidosis has not been evaluated, such as in the presence of cardiovascular complications. In this study, we will conduct a meta-analysis to clarify the role of late gadolinium enhancement in cardiovascular events in cardiac sarcoidosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electronic database searches will be PubMed, Web of Science, Cochrane advanced search, and EMBASE. The risk is assessed using odds ratios of the occurrence of cardiovascular events against the presence or absence of delayed contrast in cases of confirmed or suspected cardiac sarcoidosis.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Literature obtained by the following search formula will be considered.
#1{Cardiac sarcoidosis OR sarcoidosis OR CS}
#2{Late geranium enhancement OR LGE}
#3{Magnetic resonance imaging OR MRI}
#4 #1 AND #2 AND #3
Key exclusion criteria
References that are unsuitable for our analysis will be excluded.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Ryusuke |
| Middle name | |
| Last name | Sekii |
Organization
Yokohama City University Medical Center
Division name
Cardiovascular Center
Zip code
232-0024
Address
Urafune-cho 4-57, Minami ward, Yokohama city, Japan
TEL
045-262-5656
e113047e@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Ryusuke |
| Middle name | |
| Last name | Sekii |
Organization
Yokohama City University Medical Center
Division name
Cardiovascular center
Zip code
232-0024
Address
Urafune-cho 4-57, Minami ward, Yokohama city, Japan
TEL
045-262-5656
Homepage URL
e113047e@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
IRB of Yokohama City University Medical Center
Address
Urafune-cho 4-57, Minami ward, Yokohama city, Japan
Tel
045-261-5656
e113047e@yokohama-cu.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
| 2023 | Year | 03 | 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
| Delay expected |
Results Delay Reason
Need to reanalyze the data
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
| 2023 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Perform meta-analysis in accordance with protocol.
Management information
Registered date
| 2023 | Year | 03 | Month | 27 | Day |
Last modified on
| 2025 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057739
