UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057975 |
|---|---|
| Receipt number | R000065977 |
| Scientific Title | Comparison of the accuracy of ischemia detection between IQ-FFR (IVUS derived-FFR) and Angio derived-FFR |
| Date of disclosure of the study information | 2025/05/26 |
| Last modified on | 2025/05/26 18:59:16 |
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Basic information
Public title
Comparison of the accuracy of ischemia detection between IQ-FFR (IVUS derived-FFR) and Angio derived-FFR
Acronym
IQ-FFR vs FFRangio
Scientific Title
Comparison of the accuracy of ischemia detection between IQ-FFR (IVUS derived-FFR) and Angio derived-FFR
Scientific Title:Acronym
Comparison of the accuracy of ischemia detection between IQ-FFR (IVUS derived-FFR) and Angio derived-FFR
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the diagnostic accuracy for ischemia between virtual FFR calculated using intravascular ultrasound (IVUS) data and virtual FFR calculated using coronary angiography data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare wire-based invasive FFR measurements with IQ-FFR and angiography-derived FFR values as a reference.
Key secondary outcomes
To assess the diagnostic accuracy of IQ-FFR and angiography-derived FFR.
Base
Study type
Observational
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with ischemia based on wire-based FFR who underwent IVUS-guided PCI, and had angiography-derived FFR measurements both pre- and post-procedure.
Key exclusion criteria
A patient who has undergone neither IVUS nor angiography-based FFR assessment.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Munenori |
| Middle name | |
| Last name | Okubo |
Organization
Gifu Heart Center
Division name
Department of Cardiovascular Medicine
Zip code
500-8384
Address
4-14-4 Yabutaminami Gifu, Gifu, Japan
TEL
0582772277
munenori1971@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Munenori |
| Middle name | |
| Last name | Okubo |
Organization
Gifu Heart Center
Division name
Department of Cardiovascular Medicine
Zip code
500-8384
Address
4-14-4 Yabutaminami Gifu, Gifu, Japan
TEL
0582772277
Homepage URL
munenori1971@yahoo.co.jp
Sponsor or person
Institute
Gifu Heart Center
Institute
Department
Personal name
Funding Source
Organization
Gifu Heart Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu Heart Center
Address
4-14-4 Yabutaminami Gifu, Gifu, Japan
Tel
0582772277
mnakagawa@heart-center.or.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
岐阜ハートセンター
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | 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
200
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 | 10 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient enrollment screening is currently underway.
Management information
Registered date
| 2025 | Year | 05 | Month | 26 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065977
