Multicenter Registry for Angiography-Derived Quantitative Flow Ratio (QFRRegistry)
Multicenter Registry for Diagnostic Accuracy of Angiography-Derived Quantitative Flow Ratio to Evaluate the Hemodynamic Significance of Coronary Artery Stenosis
- to investigate the feasibility and diagnostic performance of contrast quantitative flow ratio (QFR) for identifying the functional significance of intermediate degree stenotic lesions in all-comer patients with coronary artery disease (CAD) including presentation of acute myocardial infarction (AMI) with non-culprit lesion.
- to compare the changes of contrast QFR and fractional flow reserve (FFR) according to severity of percent diameter stenosis (%DS)
- to evaluate prognostic implication of contrast QFR in comparison with FFR
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Despite potential clinical benefits and abundant evidences of FFR-guided percutaneous coronary intervention (PCI), adoption rate of FFR is still low in real world practice, most likely due to use of additional resource and to concern about side effects of hyperemic agent. Therefore, several tools to derive FFR non-invasively has been developed based on computational fluid dynamics to overcome the limitations. One of the novel methods, the contrast quantitative flow ratio (QFR) is a computation of FFR based on 3-dimensional quantitative coronary angiography (QCA) combined with Thrombolysis in Myocardial Infarction (TIMI) frame counts adjustment without hyperemic agent infusion.
Although diagnostic performance of contrast QFR for evaluation of functional significance, using FFR as reference standard, is well validated in patients with stable ischemic heart disease (SIHD), there have been lack of evidence regarding the reliability of QFR for non-culprit stenosis in patients with AMI.
Therefore, the investigators sought to investigate the feasibility and diagnostic performance of contrast QFR for identifying the functional significance of coronary stenosis in all-comer patients with CAD. In addition, prognostic implication of contrast QFR will be also compared with that of FFR.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Daegu, Korea, Republic of
- Keimyung University Dongsan Medical Center
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Goyang-si, Korea, Republic of
- Inje University Ilsan Paik Hospital
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Gwangju, Korea, Republic of
- Chosun University Hospital
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Seoul, Korea, Republic of
- Seoul National University Hospital
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Seoul, Korea, Republic of
- Samsung Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subject must be ≥18 years
- Patients suspected with ischemic heart disease
- Patients with intermediate degree of coronary artery stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery with FFR measurement
- Patients who were able to analyze QFR
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides
Exclusion Criteria:
- Left main (LM) or right coronary artery (RCA) ostial lesion
- Severe overlap of stenotic segments
- Severe tortuosity of target vessel
- Poor angiographic image quality precluding contour detection
- No optimal images with angles ≥ 25o
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
QFR Group
Patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, NSTEMI (non ST-segment elevation myocardial infarction), or STEMI (ST-segment elevation myocardial infarction) with non-culprit stenosis who underwent FFR measurement and were able to analyze QFR.
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QFR measurement in order to evaluate functional significance of epicardial stenosis and to compare the response of QFR for worsening stenosis severity, FFR value as reference standard
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic accuracy of QFR
Time Frame: through study completion, an average of 6 months
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Diagnostic accuracy of contrast QFR to predict FFR lower than 0.8
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through study completion, an average of 6 months
|
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Vessel-related composite outcome
Time Frame: through study completion, an average of 2 year
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a composite of cardiac death, vessel-related myocardial infarction, and vessel-related ischemia driven revascularization
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through study completion, an average of 2 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity of QFR
Time Frame: through study completion, an average of 6 months
|
Sensitivity of contrast QFR to predict FFR lower than 0.8
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through study completion, an average of 6 months
|
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Specificity of QFR
Time Frame: through study completion, an average of 6 months
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Specificity of contrast QFR to predict FFR lower than 0.8
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through study completion, an average of 6 months
|
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Correlation between QFR and FFR
Time Frame: through study completion, an average of 6 months
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Correlation between QFR and FFR
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through study completion, an average of 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pre-specified substudy of exercise duration after PCI
Time Frame: through study completion, an average of 3 months
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residual functional SYNTAX score calculated using post-PCI QFR will be used to define functional complete revascularization. Pre- and Post-PCI exercise treadmill test within 3 months window from PCI |
through study completion, an average of 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joo Myung Lee, MD, MPH, PhD, Samsung Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QFR2018-11-112-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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