Coronary Artery Disease
Conditions
Brief summary
The aim of this study was to investigate the accuracy of quantitative flow ratio (QFR) for predicting fractional flow reserve (FFR) ≤0.80 in an independent core laboratory.
Detailed description
FFR is an invasive physiological index used to define coronary stenosis that causes ischemia. Several studies have suggested that FFR-based percutaneous coronary intervention (PCI) can reduce adverse clinical outcomes compared to angiography-guided PCI. Although FFR is highly recommended in current guidelines, it is underused in real-world practice. QFR is a method for evaluating fractional flow reserve FFR without the use of an invasive coronary pressure wire or pharmacological hyperemic agent. The aims of this study were: 1. To investigate diagnostic accuracy of angiography-based QFR for hemodynamic assessment of coronary artery stenosis compared to pressure wire-based FFR. 2. To compare the diagnostic performance of QFR versus % diameter stenosis (DS) in identifying physiologically significant coronary artery disease (CAD) using FFR as the reference standard. 3. To identify factors affecting QFR accuracy. 4. To compare the coronary CT data with QFR.
Interventions
DIAGNOSTIC_TESTQFR
Patients suspected with CAD undergoing diagnostic coronary angiography with an indication for to perform invasive FFR were included. QFR was analyzed in an independent core laboratory (Uijeongbu Eulji Medical Center) using the software package QAngio XA 3D 2.1 (Medis Medical Imaging Systems, Leiden, the Netherlands).
Sponsors
Inje University Ilsan Paik Hospital
Keimyung University Dongsan Medical Center
Ulsan Medical Center
Sejong General Hospital
Chosun University Hospital
Severance Hospital
Ulsan University Hospital
Uijeongbu Eulji Medical Center
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients suspected with CAD undergoing diagnostic coronary angiography with an indication for to perform invasive FFR
Exclusion criteria
* Suboptimal angiographic image quality for QFR analysis * Primary myocardial or valvular disease * Left ventricular ejection fraction ≤40% * Patients with cardiogenic shock
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of QFR | through study completion, an average of 1 year | Diagnostic accuracy of QFR (≤0.80 or \>0.80) to determine hemodynamically significant coronary stenosis using invasive FFR (≤0.80 or \>0.80) as a reference standard |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of QFR | through study completion, an average of 1 year | Sensitivity of contrast QFR to predict FFR lower than 0.8 |
| Specificity of QFR | through study completion, an average of 1 year | Specificity of contrast QFR to predict FFR lower than 0.8 |
| Correlation | through study completion, an average of 1 year | Correlation between QFR and FFR |
Countries
South Korea
Outcome results
None listed