UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046392 |
|---|---|
| Receipt number | R000052936 |
| Scientific Title | Clinical Accuracy of Intravascular Ultrasound Quantitative Fractional Flow Reserve Calculated by Hydrodynamics Theory |
| Date of disclosure of the study information | 2021/12/16 |
| Last modified on | 2024/10/10 20:52:00 |
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Basic information
Public title
Clinical Accuracy of Intravascular Ultrasound Quantitative Fractional Flow Reserve Calculated by Hydrodynamics Theory
Acronym
IQ-FFR study
Scientific Title
Clinical Accuracy of Intravascular Ultrasound Quantitative Fractional Flow Reserve Calculated by Hydrodynamics Theory
Scientific Title:Acronym
IQ-FFR study
Region
| Japan |
Condition
Condition
Coronary Heart Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop real-time on-line measurement of FFR using intravascular ultrasound and hydrodynamics theory and to evaluate the usefulness of the method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
relationship between FFR measured by intravascular ultrasound and hydrodynamics theory and conventional method
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) patients with coronary heart disease
(2) both IQ-FFR and FFR were performed just before and after percutaneous coronary intervention
Key exclusion criteria
images not appropriate to analysis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Kawasaki |
Organization
Gifu Heart Center
Division name
Department of Cardiovascular Medicine
Zip code
500-8384
Address
4-14-4 Yabuta-minami
TEL
058-277-2277
masanori@ya2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Kawasaki |
Organization
Gifu Heart Center
Division name
Department of Cardiovascular Medicine
Zip code
500-8384
Address
4-14-4 Yabuta-minami
TEL
058-277-2277
Homepage URL
masanori@ya2.so-net.ne.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Gifu Heart Center
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, 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 Yabuta-minami
Tel
058-277-2277
masanori@ya2.so-net.ne.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
| 2021 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39374092/
Number of participants that the trial has enrolled
270
Results
We compared 270 coronary lesions with stenosis rates of 32-99%. IQ-FFR measurements were strongly correlated with the wire-derived FFR (r=0.896). In the prediction study, the clinical accuracy of predicting whether the FFR would be greater or less than 0.80 after stent implantation was 87.5%.
Results date posted
| 2024 | Year | 10 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 10 | Month | 07 | Day |
Baseline Characteristics
(1) presence of at least one stenosis (25-99%); (2) both IVUS and FFR measurement performed just before and after stent implantation, with the wire-derived FFR measured with a standard method; and (3) acquisition of clear images throughout the entire coronary branch.
Participant flow
This prospective, single-centre study included coronary lesions that met the following criteria: (1) presence of at least one stenosis (25-99%); (2) both IVUS and FFR measurement performed just before and after stent implantation, with the wire-derived FFR measured with a standard method; and (3) acquisition of clear images throughout the entire coronary branch.
Adverse events
none
Outcome measures
In the prediction study, we calculated the IQ-FFR on the assumption that one stent of arbitrary length and diameter was implanted. After stent implantation, the wire-derived FFR was measured and compared with the calculated IQ-FFR.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In the prediction study, we calculated IQ-FFR in the assumption that one stent is implanted with some length and diameter. After stent implantation, actual FFR is measured by FFR and compared with assumed IQ-FFR.
Management information
Registered date
| 2021 | Year | 12 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052936
