UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060998 |
|---|---|
| Receipt number | R000068258 |
| Scientific Title | Meta-analysis of per-vessel diagnostic performance of PET, dynamic CT perfusion, stress perfusion CMR, and SPECT for obstructive coronary artery disease using invasive FFR/iFR as the reference standard |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/20 12:31:55 |
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Basic information
Public title
Diagnostic accuracy of myocardial perfusion imaging (PET, CTP, CMR, SPECT) for coronary artery disease: a systematic review and meta-analysis using FFR/iFR as the reference standard
Acronym
Meta-analysis of noninvasive imaging vs FFR/iFR in CAD
Scientific Title
Meta-analysis of per-vessel diagnostic performance of PET, dynamic CT perfusion, stress perfusion CMR, and SPECT for obstructive coronary artery disease using invasive FFR/iFR as the reference standard
Scientific Title:Acronym
FFR/iFR-CAD Imaging Meta
Region
| Japan | North America |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the diagnostic accuracy of myocardial perfushion imaging including PET, dynamic CT perfushion, stress perfushion CMR, and SPECT, using invasive FFR or iFR as the reference standard, with per vessel analysis as primary.
In patients with suspected coronary artery disease (CAD), we will compare the per-vessel diagnostic performance of stress myocardial perfusion imaging modalities (CTP, stress perfusion MRI, PET, and SPECT). We will reconstruct TP/FP/FN/TN tables from eligible studies and estimate modality-specific pooled sensitivity and specificity and SROC curves using a bivariate random-effects (Reitsma) model.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagostic accuracy of functional CAD in each modality
Modality-specific pooled sensitivity and specificity (with 95% CIs) using the bivariate (Reitsma) model
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
known or suspected CAD
Key exclusion criteria
child, posttransplant
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Yokohama City University
Division name
Radiology
Zip code
236-0004
Address
Fukuura3-9-9, Kanazawa, Yokohama
TEL
0457872800
e113047e@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Ryusuke |
| Middle name | |
| Last name | Sekii |
Organization
Yokohama City University
Division name
Radiology
Zip code
236-0004
Address
Fukuura 3-9-9, Kanazawa, Yokohama
TEL
0457872800
Homepage URL
e113047e@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
None
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
Yokohama City University
Address
Fukuura 3-9-9, Kanazawa, Yokohama
Tel
0457872800
e113047e@yokohama-cu.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
| 2026 | Year | 04 | Month | 01 | 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
5496
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Each study identified by the search strategy will be reviewed to determine its eligibility for inclusion.
Management information
Registered date
| 2026 | Year | 03 | Month | 20 | Day |
Last modified on
| 2026 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068258
