UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058884 |
|---|---|
| Receipt number | R000067344 |
| Scientific Title | Diagnostic Performance of FFR-CT for Detecting Functional Ischemia in Patients with Moderate Stenosis on Coronary CT Performed for the Evaluation of Stable Angina: A Systematic Review and Meta-Analysis |
| Date of disclosure of the study information | 2025/08/26 |
| Last modified on | 2025/08/25 11:06:03 |
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Basic information
Public title
Diagnostic Performance of FFR-CT for Detecting Functional Ischemia in Patients with Moderate Stenosis on Coronary CT Performed for the Evaluation of Stable Angina: A Systematic Review and Meta-Analysis
Acronym
Diagnostic Performance of FFR-CT for Detecting Functional Ischemia in Patients with Moderate Stenosis on Coronary CT Performed for the Evaluation of Stable Angina: A Systematic Review and Meta-Analysis
Scientific Title
Diagnostic Performance of FFR-CT for Detecting Functional Ischemia in Patients with Moderate Stenosis on Coronary CT Performed for the Evaluation of Stable Angina: A Systematic Review and Meta-Analysis
Scientific Title:Acronym
Diagnostic Performance of FFR-CT for Detecting Functional Ischemia in Patients with Moderate Stenosis on Coronary CT Performed for the Evaluation of Stable Angina: A Systematic Review and Meta-Analysis
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Medicine in general | Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Coronary computed tomography (CT) is widely used for the evaluation of stable angina, and accurate assessment of the functional significance of moderate stenosis is essential. However, morphological assessment alone often fails to reliably determine the presence of ischemia. Recently, fractional flow reserve derived from CT (FFR-CT) has emerged as a promising noninvasive technique for functional assessment, but its diagnostic performance remains incompletely established. The objective of this study was to systematically evaluate the diagnostic performance of FFR-CT for detecting functional ischemia in patients with moderate stenosis on coronary CT performed for the evaluation of stable angina.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(Outcomes Based on FFR < 0.80 as the Reference Standard)
Outcome 1: Diagnostic accuracy of CT-FFR in all patients
Outcome 2: Diagnostic accuracy of CT-FFR in patients with moderate stenosis
Outcome 3: Diagnostic accuracy of CT-FFR according to different software in patients with moderate 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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Studies were eligible if they evaluated the diagnostic performance of CT-FFR using invasive FFR < 0.80 as the reference standard in patients undergoing coronary CT for the evaluation of stable angina, including those with moderate stenosis. Eligible outcomes included the diagnostic accuracy of CT-FFR in all patients, in patients with moderate stenosis, and stratified by different software. Only original research articles with clearly defined study populations and sufficient quantitative data (e.g., sensitivity, specificity, or AUC) compared against invasive FFR were included.
Key exclusion criteria
Reviews, case reports, conference abstracts, and non-human studies were excluded. Studies that did not use FFR < 0.80 as the reference standard, did not provide sufficient quantitative data on CT-FFR diagnostic performance, or were duplicate publications were also excluded. Articles not published in English were excluded as well.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Yokohama City University Graduate School of Medicine
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
Japan
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
神奈川県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a systematic review and meta-analysis focusing on patients with stable angina who underwent coronary CT and were found to have moderate stenosis. Using invasive FFR < 0.80 as the reference standard, the diagnostic performance of CT-FFR was evaluated in all patients, in those with moderate stenosis, and stratified by different software. As this is a secondary analysis of previously published studies, no new patient enrollment or intervention will be conducted.
Management information
Registered date
| 2025 | Year | 08 | Month | 25 | Day |
Last modified on
| 2025 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067344
