<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/NCT02973126</url>
  </required_header>
  <id_info>
    <org_study_id>016-096</org_study_id>
    <nct_id>NCT02973126</nct_id>
  </id_info>
  <brief_title>Heartflow (AFFECTS)</brief_title>
  <acronym>AFFECTS</acronym>
  <official_title>Assessment of Fractional Flow reservE Computed Tomography Versus Single Photon Emission Computed Tomography in the Diagnosis of Hemodynamically Significant Coronary Artery Disease. (AFFECTS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective of the AFFECTS Study is to assess agreement between SPECT and FFRct in&#xD;
      identifying vessel-specific, hemodynamically significant CAD in patients scheduled for&#xD;
      invasive coronary angiography (ICA) based on abnormal SPECT myocardial perfusion scans. In&#xD;
      particular, the study will evaluate the ability of FFRct to correctly rule out&#xD;
      hemodynamically significant CAD in patients with non-significant CAD or normal coronary&#xD;
      arteries who had positive SPECT scans.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Anticipated">July 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Positive finding of hemodynamically significant CAD according to SPECT.</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive finding of hemodynamically significant CAD according to FFRct.</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive finding of hemodynamically significant CAD according to ICA +/- iFFR.</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physician intuition regarding presence of vessel-specific, hemodynamically significant CAD after review of FFRct results.</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative radiation exposure in the study cohort during SPECT, cCTA, and ICA and potential impact of FFRct in reducing radiation exposure in patients with no hemodynamically significant CAD.</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential economic impact of FFRct in decreasing referral to ICA in patients without hemodynamically significant CAD.</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">270</enrollment>
  <condition>Cardiovascular Abnormalities</condition>
  <arm_group>
    <arm_group_label>FFRct versus SPECT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Comparison of the diagnostic performance of FFRct and SPECT in subjects with suspected stable CAD</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>FFRct and SPECT</intervention_name>
    <description>enable the comparison of diagnostic performance of FFRct and SPECT in subjects with suspected stable CAD after abnormal SPECT imaging who have no contraindications to coronary computed tomography angiography (CCTA).</description>
    <arm_group_label>FFRct versus SPECT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Providing written informed consent&#xD;
&#xD;
          -  Subjects with abnormal SPECT myocardial perfusion imaging results who have been&#xD;
             referred for clinically indicated ICA within 90-days of SPECT.&#xD;
&#xD;
          -  Ability to undergo cCTA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute coronary syndrome (ACS).&#xD;
&#xD;
          -  Prior, clinically documented, myocardial infarction (MI).&#xD;
&#xD;
          -  Prior coronary artery bypass grafting (CABG)&#xD;
&#xD;
          -  Prior coronary stenting&#xD;
&#xD;
          -  Evidence of ongoing or active clinical instability including unstable angina,&#xD;
             intractable arrhythmia, cardiogenic shock, unstable BP, and severe CHF (NYHA class III&#xD;
             or IV) or acute pulmonary edema&#xD;
&#xD;
          -  Contraindications for cCTA such as:&#xD;
&#xD;
               1. Presence of pacemaker or internal defibrillator leads such that coronary&#xD;
                  visualization is impaired&#xD;
&#xD;
               2. Chronic atrial fibrillation with uncontrolled ventricular response&#xD;
&#xD;
               3. Known anaphylactic allergy to iodinated contrast that cannot be pre-medicated&#xD;
&#xD;
               4. Pregnancy or unknown pregnancy status in women of childbearing age&#xD;
&#xD;
               5. Contraindication to acute beta blockade&#xD;
&#xD;
               6. Contraindication to acute sublingual nitrate administration&#xD;
&#xD;
               7. Prosthetic heart valve such that coronary visualization is impaired&#xD;
&#xD;
          -  Contraindications for FFRct such as:&#xD;
&#xD;
               1. Complex congenital heart disease other than anomalous coronary origins alone&#xD;
&#xD;
               2. Ventricular septal defect with known Qp/Qs &gt; 1.4&#xD;
&#xD;
          -  Requiring an emergent procedure within 48 hours of presentation&#xD;
&#xD;
          -  Any active, serious, life-threatening disease with life expectancy less than 2 months&#xD;
&#xD;
          -  Inability to comply with study procedures&#xD;
&#xD;
          -  Current participation in any other clinical trial involving an investigational device,&#xD;
             drug, or dictating care pathways at the time of enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Brown, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Heart Hospital Baylor Plano</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2022</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>Cardiovascular Abnormalities</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02973126
org study id: 016-096
nct id: NCT02973126
lead sponsor: 
has dmc: Yes
The overall objective of the AFFECTS Study is to assess agreement between SPECT and FFRct in
      identifying vessel-specific, hemodynamically significant CAD in patients scheduled for
      invasive coronary angiography (ICA) based on abnormal SPECT myocardial perfusion scans. In
      particular, the study will evaluate the ability of FFRct to correctly rule out
      hemodynamically significant CAD in patients with non-significant CAD or normal coronary
      arteries who had positive SPECT scans.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Positive finding of hemodynamically significant CAD according to SPECT.
time frame: 24 months
measure: Positive finding of hemodynamically significant CAD according to FFRct.
time frame: 24 months
measure: Positive finding of hemodynamically significant CAD according to ICA +/- iFFR.
time frame: 24 months
measure: Physician intuition regarding presence of vessel-specific, hemodynamically significant CAD after review of FFRct results.
time frame: 24 months
measure: Cumulative radiation exposure in the study cohort during SPECT, cCTA, and ICA and potential impact of FFRct in reducing radiation exposure in patients with no hemodynamically significant CAD.
time frame: 24 months
measure: Potential economic impact of FFRct in decreasing referral to ICA in patients without hemodynamically significant CAD.
time frame: 24 months
arm group label: FFRct versus SPECT
arm group type: Other
description: Comparison of the diagnostic performance of FFRct and SPECT in subjects with suspected stable CAD
intervention type: Procedure
intervention name: FFRct and SPECT
description: enable the comparison of diagnostic performance of FFRct and SPECT in subjects with suspected stable CAD after abnormal SPECT imaging who have no contraindications to coronary computed tomography angiography (CCTA).
arm group label: FFRct versus SPECT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Brown, MD
role: Principal Investigator
affiliation: Baylor Research Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cardiovascular Abnormalities
sharing ipd: No