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Completed

NCT Number: NCT06305572

Diagnostic Accuracy of Quantitative Flow Ratio

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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:

  • To investigate diagnostic accuracy of angiography-based QFR for hemodynamic assessment of coronary artery stenosis compared to pressure wire-based FFR.
  • 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.
  • To identify factors affecting QFR accuracy.
  • To compare the coronary CT data with QFR.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QFR

Diagnostic Test

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).

Primary outcomes

  1. Diagnostic accuracy of QFR

    Time frame: 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 outcomes

  1. Sensitivity of QFR

    Time frame: through study completion, an average of 1 year

    Sensitivity of contrast QFR to predict FFR lower than 0.8

  2. Specificity of QFR

    Time frame: through study completion, an average of 1 year

    Specificity of contrast QFR to predict FFR lower than 0.8

  3. Correlation

    Time frame: through study completion, an average of 1 year

    Correlation between QFR and FFR

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Chosun University Hospital
  • Inje University Ilsan Paik Hospital
  • Keimyung University Dongsan Medical Center
  • Sejong General Hospital
  • Severance Hospital
  • Uijeongbu Eulji University Hospital
  • Ulsan Medical Center
  • Ulsan University Hospital

Registry information

Official study title

Diagnostic Accuracy of Quantitative Flow Ratio for Hemodynamic Assessment of Coronary Artery Stenosis: Prospective Observational Study

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2024
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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