Ischemic Heart Disease
Conditions
Keywords
Stable angina, Acute Myocardial Infarction, Fractional Flow Reserve, Quantitative Flow Ratio
Brief summary
1. 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. 2. to compare the changes of contrast QFR and fractional flow reserve (FFR) according to severity of percent diameter stenosis (%DS) 3. to evaluate prognostic implication of contrast QFR in comparison with FFR
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.
Interventions
DIAGNOSTIC_TESTQFR assessment
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
Sponsors
Seoul National University Hospital
Inje University
Dongsan Medical Center
Chosun University Hospital
Samsung Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of QFR | through study completion, an average of 6 months | Diagnostic accuracy of contrast QFR to predict FFR lower than 0.8 |
| Vessel-related composite outcome | through study completion, an average of 2 year | a composite of cardiac death, vessel-related myocardial infarction, and vessel-related ischemia driven revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of QFR | through study completion, an average of 6 months | Sensitivity of contrast QFR to predict FFR lower than 0.8 |
| Specificity of QFR | through study completion, an average of 6 months | Specificity of contrast QFR to predict FFR lower than 0.8 |
| Correlation between QFR and FFR | through study completion, an average of 6 months | Correlation between QFR and FFR |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pre-specified substudy of exercise duration after PCI | through study completion, an average of 3 months | 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 |
Countries
South Korea
Outcome results
None listed