Multicenter Registry for Angiography-Derived Quantitative Flow Ratio (QFRRegistry)

November 20, 2023 updated by: Joo Myung Lee, Samsung Medical Center

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

  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

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

524

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

      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Goyang-si, Korea, Republic of
        • Inje University Ilsan Paik Hospital
      • Gwangju, Korea, Republic of
        • Chosun university hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

320 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment elevation MI with non-culprit stenosis who underwent FFR measurement and were able to analyze QFR

Description

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

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
QFR Group
Patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, NSTEMI (non ST-segment elevation myocardial infarction), or STEMI (ST-segment elevation myocardial infarction) with non-culprit stenosis who underwent FFR measurement and were able to analyze QFR.
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

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 6 months
Diagnostic accuracy of contrast QFR to predict FFR lower than 0.8
through study completion, an average of 6 months
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
through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of QFR
Time Frame: through study completion, an average of 6 months
Sensitivity of contrast QFR to predict FFR lower than 0.8
through study completion, an average of 6 months
Specificity of QFR
Time Frame: through study completion, an average of 6 months
Specificity of contrast QFR to predict FFR lower than 0.8
through study completion, an average of 6 months
Correlation between QFR and FFR
Time Frame: through study completion, an average of 6 months
Correlation between QFR and FFR
through study completion, an average of 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

through study completion, an average of 3 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Joo Myung Lee, MD, MPH, PhD, Samsung Medical Center

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)

April 30, 2016

Primary Completion (Actual)

October 1, 2022

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

December 28, 2018

First Submitted That Met QC Criteria

December 31, 2018

First Posted (Actual)

January 3, 2019

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

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.

Clinical Trials on Ischemic Heart Disease

Clinical Trials on QFR assessment

Subscribe