UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058432 |
|---|---|
| Receipt number | R000066780 |
| Scientific Title | Validation of Murray Law-Based Quantitative Flow Ratio Derived from Coronary CT Angiography after PCI with Stent Implantation |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/11 13:00:10 |
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Basic information
Public title
Validation of Murray Law-Based Quantitative Flow Ratio Derived from Coronary CT Angiography after PCI with Stent Implantation
Acronym
Validation of Murray Law-Based Quantitative Flow Ratio Derived from Coronary CT Angiography after PCI with Stent Implantation
Scientific Title
Validation of Murray Law-Based Quantitative Flow Ratio Derived from Coronary CT Angiography after PCI with Stent Implantation
Scientific Title:Acronym
Validation of Murray Law-Based Quantitative Flow Ratio Derived from Coronary CT Angiography after PCI with Stent Implantation
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to validate the assessment of the quantitative flow ratio based on Murray law-based coronary computed tomography angiography in coronary vessels after stent implantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic performance of Murray law-based quantitative flow ratio derived from coronary computed tomography angiography in coronary vessels after stent implantation using fractional flow reserve as the reference standard
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
Patients with suspected recurrent or residual angina after coronary stent implantation who underwent coronary computed tomography angiography (cCTA).
Patients who had fractional flow reserve (FFR) measured using a pressure wire in the stented vessel within 3 months before or after the cCTA.
Key exclusion criteria
Patients with chronic total occlusion (CTO) lesions
Patients with acute myocardial infarction (AMI) within the past 2 months
Patients who underwent PCI or coronary artery bypass grafting (CABG) on the target vessel between cCTA and FFR
Patients whose cCTA images were deemed uninterpretable
Patients who declined participation in the study based on publicly disclosed information
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takayoshi |
| Middle name | |
| Last name | Toba |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5111
taka0222@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayoshi |
| Middle name | |
| Last name | Toba |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5111
Homepage URL
taka0222@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
the Ethics Committee of Kobe University Hospital
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
078-382-5846
kansatsu@med.kobe-u.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
| 2025 | Year | 08 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 07 | Month | 11 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066780
