<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04493086</url>
  </required_header>
  <id_info>
    <org_study_id>FFR</org_study_id>
    <nct_id>NCT04493086</nct_id>
  </id_info>
  <brief_title>Effect of FFRCT-angio in Functional Diagnosis of Coronary Artery Stenosis</brief_title>
  <official_title>Effect of FFRCT-angio in Functional Diagnosis of Coronary Artery Stenosis: a Prospective, Multicenter Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Harbin Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital of Harbin Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coronary CT angiography (CTA) or invasive coronary angiography (CAG) is usually performed to&#xD;
      evaluate the severity of coronary stenosis depending on the probability of CAD. However, the&#xD;
      stenosis severity is not closely corresponding with the hemodynamic significance in coronary&#xD;
      arteries.&#xD;
&#xD;
      As a result, fractional flow reserve (FFR) with pressure wire measurement was introduced to&#xD;
      functionally assess the coronary stenosis. FFR is defined as the ratio of maximum blood flow&#xD;
      distal to a stenotic lesion under hyperemia state to normal maximum flow in the same vessel.&#xD;
      The cutoff value of FFR to detect significant ischemia is set to be 0.80, indicating that PCI&#xD;
      should be considered if FFR≤0.80. However, FFR does have some limitations, such as risks of&#xD;
      pressure wire injury, extra time and cost, and side effects of hyperemic agents.&#xD;
&#xD;
      To overcome the limitations of FFR, CTA- and CAG-based methods to functionally assess&#xD;
      coronary stenosis were proposed, i.e. FFR derived from CTA (FFRCT) and FFR derived from&#xD;
      angiography-based quantitative flow ratio (QFR), which can simultaneously evaluate anatomic&#xD;
      and hemodynamic significance of stenotic lesions. A number of studies have demonstrated that&#xD;
      FFRCT has high sensitivity and specificity in identifying myocardial ischemia. However, the&#xD;
      diagnostic accuracy of FFRCT depends on the image quality of coronary CTA, and it is&#xD;
      relatively low in lesions with severe calcification and/or tortuosity. Besides, the&#xD;
      methodology of FFRCT relies on computational fluid dynamics, which is complicated and time&#xD;
      consuming. As for QFR, it is a novel method for deriving FFR based on 3-dimensional&#xD;
      quantitative coronary angiography (3D-QCA) and contrast frame counting during CAG. Recent&#xD;
      studies have shown that QFR has good diagnostic performance in evaluating the functional&#xD;
      significance of coronary stenosis. The accuracy of QFR is also highly associated with&#xD;
      anatomic information, thereby its diagnostic accuracy may be decreased in diffuse, tandem,&#xD;
      thrombus-containing, calcified, or torturous lesions, and it is not suitable for prior&#xD;
      infarction-related or collateral donor arteries as well. Given the above issues concerning&#xD;
      FFRCT and QFR, we proposed a novel approach that integrates coronary CTA and CAG images to&#xD;
      calculate FFR (FFRCT-angio) using artificial intelligence. The present study was undertaken&#xD;
      to test the diagnostic accuracy of FFRCT-angio in patients with SCAD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cardiovascular disease remains the leading cause of death worldwide, and stable coronary&#xD;
      artery disease (SCAD) accounts for the greatest proportion of cardiovascular disease. In the&#xD;
      past decades, percutaneous coronary intervention (PCI) has become one of the most common&#xD;
      treatments for SCAD, and therefore assessing the hemodynamic significance of coronary&#xD;
      stenosis is important for physicians to make the optimal treating strategy. Coronary CT&#xD;
      angiography (CTA) or invasive coronary angiography (CAG) is usually performed to evaluate the&#xD;
      severity of coronary stenosis depending on the probability of CAD. However, the stenosis&#xD;
      severity is not closely corresponding with the hemodynamic significance in coronary arteries.&#xD;
&#xD;
      As a result, fractional flow reserve (FFR) with pressure wire measurement was introduced to&#xD;
      functionally assess the coronary stenosis. FFR is defined as the ratio of maximum blood flow&#xD;
      distal to a stenotic lesion under hyperemia state to normal maximum flow in the same vessel.&#xD;
      The cutoff value of FFR to detect significant ischemia is set to be 0.80, indicating that PCI&#xD;
      should be considered if FFR≤0.80. FAME (Fractional Flow Reserve versus Angiography for&#xD;
      Multivessel Evaluation) study confirmed that FFR guided PCI was superior to angiography&#xD;
      guided PCI in reducing major adverse cardiovascular events (MACE) in patients with&#xD;
      multivessel disease. In the subsequent FAME 2 study, FFR guided PCI plus the optimal medical&#xD;
      treatment (OMT), as compared with the OMT alone, decreased the composite event rates mainly&#xD;
      driven by urgent revascularization in SCAD patients. However, FFR does have some limitations,&#xD;
      such as risks of pressure wire injury, extra time and cost, and side effects of hyperemic&#xD;
      agents.&#xD;
&#xD;
      To overcome the limitations of FFR, CTA- and CAG-based methods to functionally assess&#xD;
      coronary stenosis were proposed, i.e. FFR derived from CTA (FFRCT) and FFR derived from&#xD;
      angiography-based quantitative flow ratio (QFR), which can simultaneously evaluate anatomic&#xD;
      and hemodynamic significance of stenotic lesions. A number of studies have demonstrated that&#xD;
      FFRCT has high sensitivity and specificity in identifying myocardial ischemia. However, the&#xD;
      diagnostic accuracy of FFRCT depends on the image quality of coronary CTA, and it is&#xD;
      relatively low in lesions with severe calcification and/or tortuosity. Besides, the&#xD;
      methodology of FFRCT relies on computational fluid dynamics, which is complicated and time&#xD;
      consuming. As for QFR, it is a novel method for deriving FFR based on 3-dimensional&#xD;
      quantitative coronary angiography (3D-QCA) and contrast frame counting during CAG. Recent&#xD;
      studies have shown that QFR has good diagnostic performance in evaluating the functional&#xD;
      significance of coronary stenosis. The accuracy of QFR is also highly associated with&#xD;
      anatomic information, thereby its diagnostic accuracy may be decreased in diffuse, tandem,&#xD;
      thrombus-containing, calcified, or torturous lesions, and it is not suitable for prior&#xD;
      infarction-related or collateral donor arteries as well. Given the above issues concerning&#xD;
      FFRCT and QFR, we proposed a novel approach that integrates coronary CTA and CAG images to&#xD;
      calculate FFR (FFRCT-angio) using artificial intelligence. The present study was undertaken&#xD;
      to test the diagnostic accuracy of FFRCT-angio in patients with SCAD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>By taking FFR value as the standard, evaluating the accuracy of FFRCT-angio in the functional significance of coronary stenosis</measure>
    <time_frame>5 days</time_frame>
    <description>By taking FFR value as the standard, evaluating the accuracy of FFRCT-angio in the functional significance of coronary stenosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>By taking FFR value as the standard, evaluating the sensitivity and specificity of FFRCT-angio in the functional significance of coronary stenosis</measure>
    <time_frame>5 days</time_frame>
    <description>By taking FFR value as the standard, evaluating the sensitivity and specificity of FFRCT-angio in the functional significance of coronary stenosis</description>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Coronary Artery Disease</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>FFRCT-angio</intervention_name>
    <description>According to invasive coronary angiography (CAG) images, image databases of critical lesions, diffuse lesions, left main trunk lesions, ostium lesions and bifurcation lesions were established. In order to ensure that the position of the pressure guide wire sensor is consistent with that of FFRCT-angio, a professional with unknown FFR results is used to mark the position of the pressure wire sensor on the CAG image. The clinical information and characteristics of coronary artery lesions were collected, and the baseline data of patients were completed. The accuracy and diagnostic performance of FFRCT-angio in the diagnosis of functional stenosis (FFR &lt; 0.8) were evaluated with FFR value measured by pressure guide wire as reference standard.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with stable coronary heart disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with stable coronary heart disease undergoing CTA.&#xD;
&#xD;
          -  Patients with at least one coronary artery stenosis of 50% - 90% in diameter ≥ 2mm.&#xD;
&#xD;
          -  Within 30 days after CTA, CAG and FFR were determined by clinicians according to their&#xD;
             condition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with myocardial infarction within 72 hours.&#xD;
&#xD;
          -  Patients with coronary artery thrombosis.&#xD;
&#xD;
          -  Patients with a history of allergy to contrast media or adenosine.&#xD;
&#xD;
          -  NYHA class III-IV patients.&#xD;
&#xD;
          -  Patients with previous CABG, target vessel PCI, pacemaker, ICD.&#xD;
&#xD;
          -  Patients with a history of prosthetic valve implantation.&#xD;
&#xD;
          -  Patients with myocardial bridges in the target vessels.&#xD;
&#xD;
          -  Patients with severe arrhythmia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yue Li, PhD</last_name>
    <phone>86-451-85552216</phone>
    <email>ly99ly@vip.163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jingyi Xue, PhD</last_name>
    <phone>86-451-85555672</phone>
    <email>xuejingyi72@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>the first affiliated hospital of Harbin medical university</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yue Li, PhD</last_name>
      <phone>86-451-85552216</phone>
      <email>ly99ly@vip.163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Coronary Stenosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04493086
org study id: FFR
nct id: NCT04493086
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Coronary CT angiography (CTA) or invasive coronary angiography (CAG) is usually performed to
      evaluate the severity of coronary stenosis depending on the probability of CAD. However, the
      stenosis severity is not closely corresponding with the hemodynamic significance in coronary
      arteries.

      As a result, fractional flow reserve (FFR) with pressure wire measurement was introduced to
      functionally assess the coronary stenosis. FFR is defined as the ratio of maximum blood flow
      distal to a stenotic lesion under hyperemia state to normal maximum flow in the same vessel.
      The cutoff value of FFR to detect significant ischemia is set to be 0.80, indicating that PCI
      should be considered if FFR≤0.80. However, FFR does have some limitations, such as risks of
      pressure wire injury, extra time and cost, and side effects of hyperemic agents.

      To overcome the limitations of FFR, CTA- and CAG-based methods to functionally assess
      coronary stenosis were proposed, i.e. FFR derived from CTA (FFRCT) and FFR derived from
      angiography-based quantitative flow ratio (QFR), which can simultaneously evaluate anatomic
      and hemodynamic significance of stenotic lesions. A number of studies have demonstrated that
      FFRCT has high sensitivity and specificity in identifying myocardial ischemia. However, the
      diagnostic accuracy of FFRCT depends on the image quality of coronary CTA, and it is
      relatively low in lesions with severe calcification and/or tortuosity. Besides, the
      methodology of FFRCT relies on computational fluid dynamics, which is complicated and time
      consuming. As for QFR, it is a novel method for deriving FFR based on 3-dimensional
      quantitative coronary angiography (3D-QCA) and contrast frame counting during CAG. Recent
      studies have shown that QFR has good diagnostic performance in evaluating the functional
      significance of coronary stenosis. The accuracy of QFR is also highly associated with
      anatomic information, thereby its diagnostic accuracy may be decreased in diffuse, tandem,
      thrombus-containing, calcified, or torturous lesions, and it is not suitable for prior
      infarction-related or collateral donor arteries as well. Given the above issues concerning
      FFRCT and QFR, we proposed a novel approach that integrates coronary CTA and CAG images to
      calculate FFR (FFRCT-angio) using artificial intelligence. The present study was undertaken
      to test the diagnostic accuracy of FFRCT-angio in patients with SCAD.
Cardiovascular disease remains the leading cause of death worldwide, and stable coronary
      artery disease (SCAD) accounts for the greatest proportion of cardiovascular disease. In the
      past decades, percutaneous coronary intervention (PCI) has become one of the most common
      treatments for SCAD, and therefore assessing the hemodynamic significance of coronary
      stenosis is important for physicians to make the optimal treating strategy. Coronary CT
      angiography (CTA) or invasive coronary angiography (CAG) is usually performed to evaluate the
      severity of coronary stenosis depending on the probability of CAD. However, the stenosis
      severity is not closely corresponding with the hemodynamic significance in coronary arteries.

      As a result, fractional flow reserve (FFR) with pressure wire measurement was introduced to
      functionally assess the coronary stenosis. FFR is defined as the ratio of maximum blood flow
      distal to a stenotic lesion under hyperemia state to normal maximum flow in the same vessel.
      The cutoff value of FFR to detect significant ischemia is set to be 0.80, indicating that PCI
      should be considered if FFR≤0.80. FAME (Fractional Flow Reserve versus Angiography for
      Multivessel Evaluation) study confirmed that FFR guided PCI was superior to angiography
      guided PCI in reducing major adverse cardiovascular events (MACE) in patients with
      multivessel disease. In the subsequent FAME 2 study, FFR guided PCI plus the optimal medical
      treatment (OMT), as compared with the OMT alone, decreased the composite event rates mainly
      driven by urgent revascularization in SCAD patients. However, FFR does have some limitations,
      such as risks of pressure wire injury, extra time and cost, and side effects of hyperemic
      agents.

      To overcome the limitations of FFR, CTA- and CAG-based methods to functionally assess
      coronary stenosis were proposed, i.e. FFR derived from CTA (FFRCT) and FFR derived from
      angiography-based quantitative flow ratio (QFR), which can simultaneously evaluate anatomic
      and hemodynamic significance of stenotic lesions. A number of studies have demonstrated that
      FFRCT has high sensitivity and specificity in identifying myocardial ischemia. However, the
      diagnostic accuracy of FFRCT depends on the image quality of coronary CTA, and it is
      relatively low in lesions with severe calcification and/or tortuosity. Besides, the
      methodology of FFRCT relies on computational fluid dynamics, which is complicated and time
      consuming. As for QFR, it is a novel method for deriving FFR based on 3-dimensional
      quantitative coronary angiography (3D-QCA) and contrast frame counting during CAG. Recent
      studies have shown that QFR has good diagnostic performance in evaluating the functional
      significance of coronary stenosis. The accuracy of QFR is also highly associated with
      anatomic information, thereby its diagnostic accuracy may be decreased in diffuse, tandem,
      thrombus-containing, calcified, or torturous lesions, and it is not suitable for prior
      infarction-related or collateral donor arteries as well. Given the above issues concerning
      FFRCT and QFR, we proposed a novel approach that integrates coronary CTA and CAG images to
      calculate FFR (FFRCT-angio) using artificial intelligence. The present study was undertaken
      to test the diagnostic accuracy of FFRCT-angio in patients with SCAD.
observational model: Cohort
time perspective: Prospective
measure: By taking FFR value as the standard, evaluating the accuracy of FFRCT-angio in the functional significance of coronary stenosis
time frame: 5 days
description: By taking FFR value as the standard, evaluating the accuracy of FFRCT-angio in the functional significance of coronary stenosis
measure: By taking FFR value as the standard, evaluating the sensitivity and specificity of FFRCT-angio in the functional significance of coronary stenosis
time frame: 5 days
description: By taking FFR value as the standard, evaluating the sensitivity and specificity of FFRCT-angio in the functional significance of coronary stenosis
intervention type: Diagnostic Test
intervention name: FFRCT-angio
description: According to invasive coronary angiography (CAG) images, image databases of critical lesions, diffuse lesions, left main trunk lesions, ostium lesions and bifurcation lesions were established. In order to ensure that the position of the pressure guide wire sensor is consistent with that of FFRCT-angio, a professional with unknown FFR results is used to mark the position of the pressure wire sensor on the CAG image. The clinical information and characteristics of coronary artery lesions were collected, and the baseline data of patients were completed. The accuracy and diagnostic performance of FFRCT-angio in the diagnosis of functional stenosis (FFR < 0.8) were evaluated with FFR value measured by pressure guide wire as reference standard.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Yue Li, PhD
phone: 86-451-85552216
email: ly99ly@vip.163.com
last name: Jingyi Xue, PhD
phone: 86-451-85555672
email: xuejingyi72@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Coronary Stenosis