Diagnostic Accuracy of Quantitative Flow Ratio

Completed

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: QFR

• Registration Number: NCT06305572
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2019-07-30
• Primary Completion: 2023-03-25
• Study Completion: 2023-09-26
• Status Verified: 2024-03
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-10
• Last Update Submitted: 2024-03-10
• Study First Posted: 2024-03-12
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
QFR group	QFR	Patients suspected with coronary artery disease undergoing diagnostic coronary angiography with an indication for to perform invasive FFR

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Sensitivity of QFR	through study completion, an average of 1 year	Sensitivity of contrast QFR to predict FFR lower than 0.8

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of