Diagnostic Accuracy of Quantitative Flow Ratio

March 10, 2024 updated by: Bon-Kwon Koo, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
QFR group
Patients suspected with coronary artery disease undergoing diagnostic coronary angiography with an indication for to perform invasive FFR
Diagnostic test: QFR
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of QFR
Time Frame: through study completion, an average of 1 year
Sensitivity of contrast QFR to predict FFR lower than 0.8
through study completion, an average of 1 year
Specificity of QFR
Time Frame: through study completion, an average of 1 year
Specificity of contrast QFR to predict FFR lower than 0.8
through study completion, an average of 1 year
Correlation
Time Frame: through study completion, an average of 1 year
Correlation between QFR and FFR
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

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

Investigators

  • Principal Investigator: Bon-Kwon Koo, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2019

Primary Completion (Actual)

March 25, 2023

Study Completion (Actual)

September 26, 2023

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 10, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 10, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1903-013-1014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The sharing plan will be decided by the study committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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