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Completed

NCT Number: NCT04102917

Diagnostic Performance and Prognostic Ability of the QFR

1. The primary technical endpoint was the diagnostic performance of the QFR against the FFR. 2. The primary clinical endpoint was target vessel failure (TVF) between two groups distributed by a QFR cut-off value of 0.8

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul Saint Mary's Hospital

Seoul, Seochogu, 06591, South Korea

About this study

The quantitative flow ratio (QFR) is a novel angiography-based tool used to assess functional ischemia caused by coronary stenosis. Computation of the fractional flow reserve (FFR) from coronary angiography is based on 3D reconstruction and fluid dynamics algorithms using a modified frame count; therefore, we do not need to induce hyperemia or perform invasive procedures with a pressure wire to measure it. During the past few years, the diagnostic accuracy of the QFR was investigated and showed favorable outcomes. However, data for patients with acute coronary syndrome are lacking. In addition, no data are available for the performance of the QFR in predicting clinical outcomes. We aim to evaluate the diagnostic performance of the QFR versus the FFR and their predictive abilities for clinical outcome in a real-world all-comer population.

The Catholic imaging and Functional Research (C-iFR) Cohort was designed to evaluate the diagnostic performance and clinical outcome predictive ability of the QFR in consecutive patients undergoing CAG and the FFR at 4 major cardiac centers in Korea from January 2012 to May 2018. All hospitals (Seoul St. Mary's Hospital, Seoul; St. Paul's Hospital, Seoul; Incheon St. Mary's Hospital, Incheon; Uijeongbu St. Mary's Hospital, Uijeongbu) perform a high volume of percutaneous coronary intervention (PCI) procedures, with more than 800 PCI procedures performed per year. This QFR registry includes demographic characteristics, clinical information, laboratory data, QFR findings, and FFR findings, with clinical outcome data collected over 4 years (a median of 2 years)

Who can participate

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

Inclusion criteria

  • subject ≥18 years
  • Patients suspected with ischemic heart disease
  • All-comer patients with SA, UA and AMI whose CAG results showed intermediate stenosis (50-70%) indicative of physiologic lesions
  • Patients whose target vessels were able to analyze QFR

Exclusion criteria

Patients with insufficient CAG data due to reasons below

  • CAG data uploading error
  • 2 projection angles <25 degrees apart
  • only 1 projection angle image exists
  • images with suboptimal contrast filling
  • images with too much panning or too much magnification
  • containing an ostial lesion of the left main coronary artery or right coronary artery
  • anatomical vessel problems including severe overlap, severe tortuosity, foreshortening, diffuse lesions, additional far distal lesion

Treatment and study plan

QFR assessment

Diagnostic Test

The quantitative flow ratio (QFR) is a novel angiography-based method for noninvasive functional assessment of intermediate coronary lesions.

Primary outcomes

  1. Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR

    Time frame: follow up of 4 years (anticipated median duration : 2 years)

    the diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of the QFR≤0.80 for identifying an FFR≤0.8 as the reference standard

  2. Target vessel failure

    Time frame: follow up of 4 years (anticipated median duration : 2 years)

    target vessel failure (TVF) between two groups distributed by a QFR cut-off value of 0.8

Secondary outcomes

  1. Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR in subgroups with a borderline FFR (≥0.75, ≤0.85)

    Time frame: follow up of 4 years (anticipated median duration : 2 years)

    the sensitivity, specificity, negative predictive value, positive predictive value of the QFR≤0.80 for identifying an FFR≤0.8 as the reference standard in subgroups with a borderline FFR (≥0.75, ≤0.85)

  2. Diagnostic accuracy, sensitivity, specificity, negative predictive value, positive predictive value of QFR in subgroups with complicated coronary lesions

    Time frame: follow up of 4 years (anticipated median duration : 2 years)

    the sensitivity, specificity, negative predictive value, positive predictive value of the QFR≤0.80 for identifying an FFR≤0.8 as the reference standard in subgroups with complicated coronary lesions, such as bifurcation lesions, a large intraluminal plaque volume, a low mean flow rate, a long lesion length, calcification, tandem lesions, and a previous history of coronary intervention

  3. All-cause death, cardiac death, nonfatal myocardial infarction, TLR and stroke

    Time frame: follow up of 4 years (anticipated median duration : 2 years)

    all-cause death, cardiac death, nonfatal myocardial infarction, TLR and stroke between two groups distributed by a QFR cut-off value of 0.80

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Collaborators

  • Incheon Saint Mary's Hospital
  • National Research Foundation of Korea
  • Seoul Saint Mary's Hospital
  • Seoul Saint Paul's Hospital
  • Uijeongbu Saint Mary's Hospital

Registry information

Official study title

The Catholic Imaging and Functional Research Cohort (C-iFR)

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Sep 25, 2019
Registry last updated
Sep 25, 2019

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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