UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053556 |
|---|---|
| Receipt number | R000061115 |
| Scientific Title | Monitoring the Efficacy of Tafamidis in ATTR Cardiac Amyloidosis by MRI-ECV: A Systematic Review and Meta-Analysis |
| Date of disclosure of the study information | 2024/02/06 |
| Last modified on | 2024/02/06 17:32:12 |
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Basic information
Public title
Monitoring the Efficacy of Tafamidis in ATTR Cardiac Amyloidosis by MRI-ECV: A Systematic Review and Meta-Analysis
Acronym
Monitoring the Efficacy of Tafamidis in ATTR Cardiac Amyloidosis by MRI-ECV: A Systematic Review and Meta-Analysis
Scientific Title
Monitoring the Efficacy of Tafamidis in ATTR Cardiac Amyloidosis by MRI-ECV: A Systematic Review and Meta-Analysis
Scientific Title:Acronym
Monitoring the Efficacy of Tafamidis in ATTR Cardiac Amyloidosis by MRI-ECV: A Systematic Review and Meta-Analysis
Region
| Japan |
Condition
Condition
Tafamidis is a drug that improves the prognosis of transthyretin amyloid cardiomyopathy (ATTR-CM), but its primary effect is inhibition rather than improvement of amyloid deposition, making it difficult to assess therapeutic efficacy. The usefulness of monitoring treatment response using extracellular volume fractions (ECVs) with magnetic resonance imaging (MRI) has been reported, and we will perform a meta-analysis to evaluate the usefulness of this method.
Classification by specialty
| Medicine in general | Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tafamidis is a drug that improves the prognosis of transthyretin amyloid cardiomyopathy (ATTR-CM), but its primary effect is inhibition rather than improvement of amyloid deposition, making it difficult to assess therapeutic efficacy. The usefulness of monitoring treatment response using extracellular volume fractions (ECVs) with magnetic resonance imaging (MRI) has been reported, and we will perform a meta-analysis to evaluate the usefulness of this method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inverse variance meta-analysis using a random effects model will be performed to evaluate the rate of change in MRI-ECV before and after tafamidis treatment. The analysis will also be performed by classifying patients into ATTR-CM types (wild-type or hereditary).
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
Search Strategy and Selection Criteria
Following the methodology proposed by the Cochrane Collaboration and adhering to the reporting criteria outlined in the 2020 Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines, we conducted a comprehensive database search using PubMed, Web of Science Core Collection, Cochrane advanced search, and EMBASE electronic databases. Use the following keywords: "tafamidis", "extracellular volume fraction", "extracellular volume", "ECV", "MRI", "cardiac MRI". Eligibility criteria present pre- and post-treatment MRI-ECV values for tafamidis and encompass all articles discoverable with the specified keywords. Exclusion criteria will be limited to case reports, animal studies, and non-English language articles.
Key exclusion criteria
Search Strategy and Selection Criteria
Following the methodology proposed by the Cochrane Collaboration and adhering to the reporting criteria outlined in the 2020 Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines, we conducted a comprehensive database search using PubMed, Web of Science Core Collection, Cochrane advanced search, and EMBASE electronic databases. Use the following keywords: "tafamidis", "extracellular volume fraction", "extracellular volume", "ECV", "MRI", "cardiac MRI". Eligibility criteria present pre- and post-treatment MRI-ECV values for tafamidis and encompass all articles discoverable with the specified keywords. Exclusion criteria will be limited to case reports, animal studies, and non-English language articles.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Department of diagnostic Radiology, Yokohama City University
Division name
Department of Diagnostic Radiology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawaku, Yokohama
TEL
045-787-2800
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
3-9, Fukuura, Kanazawaku, Yokohama
TEL
045-787-2800
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
045-787-2800
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
| 2024 | Year | 02 | Month | 06 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Following the methodology proposed by the Cochrane Collaboration and adhering to the reporting criteria outlined in the 2020 Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines, we conducted a comprehensive database search using PubMed, Web of Science Core Collection, Cochrane advanced search, and EMBASE electronic databases. Use the following keywords: "tafamidis", "extracellular volume fraction", "extracellular volume", "ECV", "MRI", "cardiac MRI". Eligibility criteria present pre- and post-treatment MRI-ECV values for tafamidis and encompass all articles discoverable with the specified keywords. Exclusion criteria will be limited to case reports, animal studies, and non-English language articles.
Management information
Registered date
| 2024 | Year | 02 | Month | 06 | Day |
Last modified on
| 2024 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061115
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