UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055257 |
|---|---|
| Receipt number | R000063141 |
| Scientific Title | Synthetic ECV as a Myocardial Fibrosis Biomarker without Blood Sampling: A Systematic Review and Meta-analysis |
| Date of disclosure of the study information | 2024/08/16 |
| Last modified on | 2025/08/22 09:59:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Synthetic ECV as a Myocardial Fibrosis Biomarker without Blood Sampling: A Systematic Review and Meta-analysis
Acronym
Synthetic ECV as a Myocardial Fibrosis Biomarker without Blood Sampling: A Systematic Review and Meta-analysis
Scientific Title
Synthetic ECV as a Myocardial Fibrosis Biomarker without Blood Sampling: A Systematic Review and Meta-analysis
Scientific Title:Acronym
Synthetic ECV as a Myocardial Fibrosis Biomarker without Blood Sampling: A Systematic Review and Meta-analysis
Region
| Japan |
Condition
Condition
Patients who undergo Cardiac MR or CT
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the correlation and agreement in the quantification of synthetic ECV and laboratory ECV from conventional Hct measurements.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
correlation coefficient and mean absolute difference between synthetic and laboratory ECV
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
We include articles describing retrospective and prospective observational studies, and randomized controlled trials.
We include studies meeting the following criteria: enrolled patients underwent cardiac MRI or CT.
Key exclusion criteria
We excluded case reports, case series, animal studies
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
+81-45-787-2800
yasuda.nao.mz@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Naofumi |
| Middle name | |
| Last name | Yasuda |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
+81-45-787-2800
Homepage URL
yasuda.nao.mz@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Diagnostic Radiology, Yokohama City University Graduate School of Medicine
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
Yokohama city university
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
Tel
+81-45-787-2800
yasuda.nao.mz@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
| 2024 | Year | 08 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1097664725000511?via%3Dihub
Number of participants that the trial has enrolled
4492
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
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We used the methods suggested by the Cochrane Collaboration and met the reporting standards of the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guideline of 2020. We conducted a database search using PubMed, Web of Science Core Collection, and EMBASE electronic database. After screening all titles and abstracts in the search results, potentially relevant studies were reviewed in full by two reviewer. Institutional review board approval was not obtained for this study because it is a meta-analysis, and therefore, does not deal with clinical patient information.
Management information
Registered date
| 2024 | Year | 08 | Month | 16 | Day |
Last modified on
| 2025 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063141
