Clinical trial NCT06305572: Diagnostic Accuracy of Quantitative Flow Ratio
Official title: Diagnostic Accuracy of Quantitative Flow Ratio for Hemodynamic Assessment of Coronary Artery Stenosis: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Inje University Ilsan Paik Hospital
name: Keimyung University Dongsan Medical Center
name: Ulsan Medical Center
name: Sejong General Hospital
name: Chosun University Hospital
name: Severance Hospital
name: Ulsan University Hospital
name: Uijeongbu Eulji Medical Center
First posted: 2024-03-12
Enrollment: 280
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suspected with CAD undergoing diagnostic coronary angiography with an indication for to perform invasive FFR were included. Clinical exclusion criteria included cardiogenic shock, reduced ejection fraction (EF ≤40%), or suboptimal angiographic image quality for QFR analysis.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy of QFR
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Sensitivity of QFR
timeFrame: through study completion, an average of 1 year
measure: Specificity of QFR
timeFrame: through study completion, an average of 1 year
measure: Correlation
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Bon-Kwon Koo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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