UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054148 |
|---|---|
| Receipt number | R000061832 |
| Scientific Title | Clinical Utility of Computed Tomography Derived Extracellular Volume Fraction in The Patients with Aortic Stenosis: A Meta-analysis |
| Date of disclosure of the study information | 2024/04/15 |
| Last modified on | 2025/04/15 18:07:57 |
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Basic information
Public title
Clinical Utility of Computed Tomography Derived Extracellular Volume Fraction in The Patients with Aortic Stenosis: A Meta-analysis
Acronym
Clinical Utility of Computed Tomography Derived Extracellular Volume Fraction in The Patients with Aortic Stenosis: A Meta-analysis
Scientific Title
Clinical Utility of Computed Tomography Derived Extracellular Volume Fraction in The Patients with Aortic Stenosis: A Meta-analysis
Scientific Title:Acronym
Clinical Utility of Computed Tomography Derived Extracellular Volume Fraction in The Patients with Aortic Stenosis: A Meta-analysis
Region
| Japan | Asia(except Japan) | North America |
| South America | Europe |
Condition
Condition
Aortic Stenosis
Classification by specialty
| Cardiology |
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 many studies suggest the usefulness of CT-ECV, its clinical use remains limited in patients with aortic stenosis. 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 use PubMed, Web of Science Core Collection, and EMBASE. To evaluate the prognostic value of CT-ECV in aortic stenosis.
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
The following search formulas will be used for the literature obtained.
#1 computed tomography OR CT
#2 extracellular volume OR ECV OR CT-ECV
#3 aortic stenosis OR AS
#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 | Jin |
| Middle name | |
| Last name | Kirigaya |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
2320024
Address
4-57 Urafunacho, Minami-ku, Yokohama City, Kanagawa Prefecture
TEL
0452615656
kirigaya@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Jin |
| Middle name | |
| Last name | Kirigaya |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
232-2202
Address
4-57 Urafunacho, Minami-ku, Yokohama City, Kanagawa Prefecture
TEL
0452615656
Homepage URL
kirigaya@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Jin Kirigaya
Funding Source
Organization
Yokohama City University
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
IRB of Yokohama City University Medical Center
Address
4-57 Urafunacho, Minami-ku, Yokohama City, Kanagawa Prefecture
Tel
0452615656
kirigaya@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 | 04 | Month | 15 | Day |
Related information
URL releasing protocol
https://academic.oup.com/ehjopen/article/5/1/oeaf007/7979210
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/ehjopen/article/5/1/oeaf007/7979210
Number of participants that the trial has enrolled
1004
Results
A literature search using PubMed, Web of Science, Cochrane, and EMBASE identified six studies assessing the association between CT-ECV and prognosis in severe aortic stenosis (AS) patients undergoing AVR (902 cases: 881 TAVR, 21 SAVR). The pooled odds ratio (OR) for predicting adverse events (all-cause death and HF hospitalization) with abnormal CT-ECV was 4.53 (95% CI: 3.13-6.57, I2=10%, P=0.50). A TAVR-only subgroup analysis (5 studies, 807 cases) showed OR 4.85 (95% CI: 3.26-7.21, I2=0%, P<0.001).
Results date posted
| 2025 | Year | 04 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 01 | Month | 26 | Day |
Baseline Characteristics
A total of 902 patients with severe aortic stenosis were included (TAVR: 881 patients, SAVR: 21 patients). Patient demographics (e.g., age, sex) were based on the included studies.
Participant flow
A total of 1,408 articles were screened from four databases. After full-text review, six studies were finally included in the meta-analysis.
Adverse events
None
Outcome measures
The primary outcome was a composite of all-cause death and hospitalization for heart failure. The prognostic value of abnormal CT-ECV was assessed using pooled odds ratios.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2024 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 14 | 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
| 2024 | Year | 04 | Month | 14 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061832
