UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053051 |
|---|---|
| Receipt number | R000060533 |
| Scientific Title | Diagnostic Accuracy and Prognostic Value of Relative Apical Sparing in Cardiac Amyloidosis: A Systematic Review and Meta-Analysis |
| Date of disclosure of the study information | 2023/12/11 |
| Last modified on | 2024/12/11 10:01:11 |
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Basic information
Public title
Diagnostic Accuracy and Prognostic Value of Relative Apical Sparing in Cardiac Amyloidosis: A Systematic Review and Meta-Analysis
Acronym
Diagnostic and Prognostic Value of Apical Sparing in Cardiac Amyloidosis
Scientific Title
Diagnostic Accuracy and Prognostic Value of Relative Apical Sparing in Cardiac Amyloidosis: A Systematic Review and Meta-Analysis
Scientific Title:Acronym
Diagnostic and Prognostic Value of Relative Apical Sparing in Cardiac Amyloidosis
Region
| Japan | Asia(except Japan) |
Condition
Condition
cardiac amyloidosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this systematic review was to investigate diagnostic test accuracy and prognostic impact of relative apical sparing in patients with cardiac amyloidosis.
Basic objectives2
Others
Basic objectives -Others
Conflicting results have been reported regarding the diagnostic and prognostic utility of relative apical sparing, and the purpose of this study was to investigate this through a systematic review and meta-analysis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pooled sensitivity, specificity, and diagnostic odds ratio
Key secondary outcomes
Prognostic value of relative apical sparing for patients with cardiac amyloidosis (hazard ratio)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A paper reporting on the diagnostic or prognostic value of relative apical sparing in cardiac amyloidosis.
Key exclusion criteria
Papers that do not state sensitivity, specificity, risk ratios, etc.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Takeuchi |
Organization
Hospital of University of Occupational and Environmental Health, School of Medicine
Division name
Department of Laboratory and Transfusion Medicine
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL
093-603-1611
takeuchi@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Takeuchi |
Organization
Hospital of University of Occupational and Environmental Health, School of Medicine
Division name
Department of Laboratory and Transfusion Medicine
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL
093-603-1611
Homepage URL
takeuchi@med.uoeh-u.ac.jp
Sponsor or person
Institute
Hospital of University of Occupational and Environmental Health, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Not applicable
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
Clinical Research Review Board, University of Occupational and Environmental Health
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
Tel
093-603-1611
rinshokenkyu@mbox.clnc.uoeh-u.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 | 12 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-24-0472/_article
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-24-0472/_article
Number of participants that the trial has enrolled
2872
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
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 10 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 10 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 10 | Day |
Other
Other related information
Literature investigating the diagnostic accuracy of relative apical sparing (RAPS) and the association between RAPS and outcomes was searched in three electronic databases (PubMed, Embase, and Scopus).
The results showed that RAPS has modest diagnostic test accuracy but no prognostic value.The paper was submitted to and accepted by the Circulation Journal.The paper is entitled "Diagnostic Accuracy and Prognostic Value of Relative Apical Sparing in Cardiac Amyloidosis - Systematic Review and Meta-Analysis" and is scheduled for publication in January 2025.
Management information
Registered date
| 2023 | Year | 12 | Month | 11 | Day |
Last modified on
| 2024 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060533
