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Completed

NCT Number: NCT03791788

Multicenter Registry for Angiography-Derived Quantitative Flow Ratio

1. to investigate the feasibility and diagnostic performance of contrast quantitative flow ratio (QFR) for identifying the functional significance of intermediate degree stenotic lesions in all-comer patients with coronary artery disease (CAD) including presentation of acute myocardial infarction (AMI) with non-culprit lesion. 2. to compare the changes of contrast QFR and fractional flow reserve (FFR) according to severity of percent diameter stenosis (%DS) 3. to evaluate prognostic implication of contrast QFR in comparison with FFR

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Key information

Conditions

Ischemic Heart Disease Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Keimyung University Dongsan Medical Center, Daegu, South Korea

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About this study

Despite potential clinical benefits and abundant evidences of FFR-guided percutaneous coronary intervention (PCI), adoption rate of FFR is still low in real world practice, most likely due to use of additional resource and to concern about side effects of hyperemic agent. Therefore, several tools to derive FFR non-invasively has been developed based on computational fluid dynamics to overcome the limitations. One of the novel methods, the contrast quantitative flow ratio (QFR) is a computation of FFR based on 3-dimensional quantitative coronary angiography (QCA) combined with Thrombolysis in Myocardial Infarction (TIMI) frame counts adjustment without hyperemic agent infusion.

Although diagnostic performance of contrast QFR for evaluation of functional significance, using FFR as reference standard, is well validated in patients with stable ischemic heart disease (SIHD), there have been lack of evidence regarding the reliability of QFR for non-culprit stenosis in patients with AMI.

Therefore, the investigators sought to investigate the feasibility and diagnostic performance of contrast QFR for identifying the functional significance of coronary stenosis in all-comer patients with CAD. In addition, prognostic implication of contrast QFR will be also compared with that of FFR.

Who can participate

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

Inclusion criteria

  • Subject must be ≥18 years
  • Patients suspected with ischemic heart disease
  • Patients with intermediate degree of coronary artery stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery with FFR measurement
  • Patients who were able to analyze QFR
  • Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides

Exclusion criteria

  • Left main (LM) or right coronary artery (RCA) ostial lesion
  • Severe overlap of stenotic segments
  • Severe tortuosity of target vessel
  • Poor angiographic image quality precluding contour detection
  • No optimal images with angles ≥ 25o

Treatment and study plan

QFR assessment

Diagnostic Test

QFR measurement in order to evaluate functional significance of epicardial stenosis and to compare the response of QFR for worsening stenosis severity, FFR value as reference standard

Primary outcomes

  1. Diagnostic accuracy of QFR

    Time frame: through study completion, an average of 6 months

    Diagnostic accuracy of contrast QFR to predict FFR lower than 0.8

  2. Vessel-related composite outcome

    Time frame: through study completion, an average of 2 year

    a composite of cardiac death, vessel-related myocardial infarction, and vessel-related ischemia driven revascularization

Secondary outcomes

  1. Sensitivity of QFR

    Time frame: through study completion, an average of 6 months

    Sensitivity of contrast QFR to predict FFR lower than 0.8

  2. Specificity of QFR

    Time frame: through study completion, an average of 6 months

    Specificity of contrast QFR to predict FFR lower than 0.8

  3. Correlation between QFR and FFR

    Time frame: through study completion, an average of 6 months

    Correlation between QFR and FFR

Other outcomes

  1. Pre-specified substudy of exercise duration after PCI

    Time frame: through study completion, an average of 3 months

    residual functional SYNTAX score calculated using post-PCI QFR will be used to define functional complete revascularization.

    Pre- and Post-PCI exercise treadmill test within 3 months window from PCI

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Chosun University Hospital
  • Dongsan Medical Center
  • Inje University
  • Seoul National University Hospital

Registry information

Official study title

Multicenter Registry for Diagnostic Accuracy of Angiography-Derived Quantitative Flow Ratio to Evaluate the Hemodynamic Significance of Coronary Artery Stenosis

Acronym: QFRRegistry

Important dates

Study start
2016
Primary completion
2022
Study completion
2023
First posted
Jan 3, 2019
Registry last updated
Apr 17, 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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