UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050988 |
|---|---|
| Receipt number | R000058119 |
| Scientific Title | Prognostic significance of CAD-RADS categories for patients with suspected coronary artery disease: A Systematic Review and Meta-analysis |
| Date of disclosure of the study information | 2023/05/04 |
| Last modified on | 2024/05/31 16:59:26 |
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Basic information
Public title
Prognostic significance of CAD-RADS categories for patients with suspected coronary artery disease: A Systematic Review and Meta-analysis
Acronym
Prognostic significance of CAD-RADS categories for patients with suspected coronary artery disease: A Systematic Review and Meta-analysis
Scientific Title
Prognostic significance of CAD-RADS categories for patients with suspected coronary artery disease: A Systematic Review and Meta-analysis
Scientific Title:Acronym
Prognostic significance of CAD-RADS categories for patients with suspected coronary artery disease: 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
The aim of this meta-analysis was to assess the prognostic importance of CAD-RADS, a reporting system for coronary artery CTA, for individuals who are suspected to have coronary artery disease.
Basic objectives2
Others
Basic objectives -Others
The aim of this meta-analysis was to assess the prognostic importance of CAD-RADS, a reporting system for coronary artery CTA, for individuals who are suspected to have coronary artery disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this meta-analysis was the hazard ratio of CAD-RADS categories in heart disease. Two reviewers (SK and MA) extracted hazard ratios of CAD-RADS categories (categories 1-5) to category = 0 from the articles. Patient characteristics such as author name, year of publication, country, patient disease, age, and gender were also investigated. Furthermore, we extracted hazard ratios for the addition of CAD-RADS for articles that demonstrated an incremental value of CAD-RADS over traditional clinical risk factors or CAC and conducted a meta-analysis.
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
On April 21, 2023, we conducted a thorough database search using PubMed, Web of Science Core Collection, Cochrane advanced search, and EMBASE electronic database. The search was performed using the following keywords: Coronary Artery Disease Reporting and Data System, CAD-RADS, coronary computed tomography, coronary CTA, coronary artery disease and stable angina pectoris
Key exclusion criteria
We excluded case reports, animal studies, and non-English articles.
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
07026335766
Homepage URL
shingo.m12226@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Shingo Kato
Funding Source
Organization
Yokohama City University
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 | 05 | Month | 04 | Day |
Related information
URL releasing protocol
Not applicable for meta-analysis.
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1093/radadv/umae007
Number of participants that the trial has enrolled
0
Results
Coronary Artery Disease-Reporting and Data System (CAD-RADS) is a standardized system for interpreting and reporting coronary computed tomography angiography results. from 37,596 exams in 13 studies were analyzed. Pooled HRs were significant for all CAD-RADS categories, with higher categories showing increased HRs. For all-cause mortality, all categories except CAD-RADS 1 showed significant HR compared to CAD-RADS 0.
Results date posted
| 2024 | Year | 05 | Month | 31 | 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
This meta-analysis aimed to evaluate the prognostic value of CAD-RADS in individuals with suspected CAD.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The primary outcome of this meta-analysis was the hazard ratio of CAD-RADS categories in heart disease. Two reviewers (SK and MA) extracted hazard ratios of CAD-RADS categories (categories 1-5) to category = 0 from the articles. Patient characteristics such as author name, year of publication, country, patient disease, age, and gender were also investigated. Furthermore, we extracted hazard ratios for the addition of CAD-RADS for articles that demonstrated an incremental value of CAD-RADS over traditional clinical risk factors or CAC and conducted a meta-analysis.
Management information
Registered date
| 2023 | Year | 05 | Month | 04 | Day |
Last modified on
| 2024 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058119
