UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050172 |
|---|---|
| Receipt number | R000057147 |
| Scientific Title | Diagnostic Accuracy of Whole Heart Coronary Magnetic Resonance Angiography: A Systematic Review and Meta-analysis |
| Date of disclosure of the study information | 2023/01/29 |
| Last modified on | 2023/11/29 09:45:02 |
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Basic information
Public title
Diagnostic Accuracy of Whole Heart Coronary Magnetic Resonance Angiography: A Systematic Review and Meta-analysis
Acronym
Diagnostic Accuracy of Whole Heart Coronary Magnetic Resonance Angiography: A Systematic Review and Meta-analysis
Scientific Title
Diagnostic Accuracy of Whole Heart Coronary Magnetic Resonance Angiography: A Systematic Review and Meta-analysis
Scientific Title:Acronym
Diagnostic Accuracy of Whole Heart Coronary Magnetic Resonance Angiography: A Systematic Review and Meta-analysis
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Whole heart coronary magnetic resonance angiography (WHCA) has been proposed as a noninvasive method for screening coronary artery disease (CAD), yet there is a paucity of data on its clinical utility. Specifically, data on the newer 3.0 Tesla WHCA technique are limited. To conduct a meta-analysis of the diagnostic performance of coronary artery WHCA for detecting significant stenosis and to investigate differences in diagnostic performance between different magnetic field strengths.
Basic objectives2
Others
Basic objectives -Others
The sensitivity and specificity of WHCA will also be analyzed.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A comprehensive search of electronic databases, including PubMed, Web of Science Core Collection, Cochrane advanced search, and EMBASE, will be conducted to evaluate the ability of coronary WHCA at different magnetic field strengths (1.5 Tesla and 3.0 Tesla) to detect significant coronary artery stenosis using summary receiver operating characteristic (ROC) curves.
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
Known or suspected CAD
Key exclusion criteria
literature such as case reports, animal studies, and non-English language articles were excluded.
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 Hospital
Division name
Department of Diagnostic Radiology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawaku, Yokohama
TEL
0457872800
Homepage URL
shingo.m12226@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Shingo Kato
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
| 2023 | Year | 01 | Month | 29 | 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
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In analysis
Management information
Registered date
| 2023 | Year | 01 | Month | 29 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057147
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
