UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049627 |
|---|---|
| Receipt number | R000056443 |
| Scientific Title | Clinical Utility of Computed Tomography Derived Extracellular Volume Fraction in Cardiovascular Disease: A Meta-analysis |
| Date of disclosure of the study information | 2022/11/28 |
| Last modified on | 2023/11/29 09:44:37 |
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Basic information
Public title
Clinical Utility of Computed Tomography Derived Extracellular Volume Fraction in Cardiovascular Disease: A Meta-analysis
Acronym
Clinical Utility of Computed Tomography Derived Extracellular Volume Fraction in Cardiovascular Disease: A Meta-analysis
Scientific Title
Clinical Utility of Computed Tomography Derived Extracellular Volume Fraction in Cardiovascular Disease: A Meta-analysis
Scientific Title:Acronym
Clinical Utility of Computed Tomography Derived Extracellular Volume Fraction in Cardiovascular Disease: A Meta-analysis
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Medicine in general | Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Computed tomography derived extracellular volume fraction (CT-ECV) has emerged as a non-invasive method to quantify myocardial fibrosis. Although there are many studies suggesting the usefulness of CT-ECV, its clinical use remains limited. Therefore, we will perform a meta-analysis to clarify the clinical value of CT-ECV.
Basic objectives2
Others
Basic objectives -Others
The prognostic value of ECV will also be examined.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electronic database searches will be PubMed, Web of Science Core Collection, Cochrane advanced search, and EMBASE. Compare CT-ECV between cardiovascular disease and controls. We will also examine differences in CT-ECV between AS and CA, since preoperative differentiation between aortic stenosis (AS) and cardiac amyloidosis (CA) is important in transcatheter aortic valve replacement.
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 (extracellular volume fraction OR extracellular volume OR ECV)
#2 (computed tomography OR CT OR cardiac computed tomography OR contrast-enhanced computed tomography)
#3 (myocardium OR myocardial OR cardiac)
#4 #1 AND #2 AND #3
Key exclusion criteria
We will exclude references that are unbeatable for our analysis, such as those with missing data.
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
TEL
0457872800
shingo.m12226@gmail.com
Public contact
Name of contact person
| 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
TEL
0457872800
Homepage URL
shingo.m12226@gmail.com
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
Address
3-9, Fukuura, Kanazawaku, Yokohama
Tel
0457872800
shingo.m12226@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
| 2022 | Year | 11 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.jacc.org/doi/10.1016/j.jcmg.2023.10.008
Publication of results
Published
Result
URL related to results and publications
https://www.jacc.org/doi/10.1016/j.jcmg.2023.10.008
Number of participants that the trial has enrolled
2545
Results
Pooled CT-derived ECV values were 28.5% (95% CI: 27.3%-29.7%) in the control, 31.9 (95% CI: 30.2%-33.8%) in the aortic stenosis, and 48.9% (95% CI: 44.5%-53.3%) in the cardiac amyloidosis group. ECV was significantly elevated in aortic stenosis (P = 0.002; vs controls) but further elevated in cardiac amyloidosis (P < 0.001; vs aortic stenosis). CT-derived ECV had a high diagnostic accuracy for cardiac amyloidosis, with sensitivity of 92.8% (95% CI: 86.7%-96.2%), specificity of 84.8% (95% CI: 68.6%-93.4%).
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 | 11 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 28 | 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 the protocol.
Management information
Registered date
| 2022 | Year | 11 | Month | 28 | 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=R000056443
