Diagnostic Accuracy of Quantitative Flow Ratio

Seoul National University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Diagnostic Test: QFR

Study type: Observational

Funder types: Other

Identifiers

NCT06305572

H-1903-013-1014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

280 participants in 1 patient group

QFR group

Description:

Patients suspected with coronary artery disease undergoing diagnostic coronary angiography with an indication for to perform invasive FFR

Treatment:

Diagnostic Test: QFR