<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/NCT02218060</url>
  </required_header>
  <id_info>
    <org_study_id>Force Cardiac</org_study_id>
    <nct_id>NCT02218060</nct_id>
  </id_info>
  <brief_title>Coronary CT Angiography Using a Novel 3rd Generation Dual-Source CT System</brief_title>
  <official_title>Coronary CT Angiography Using a Novel 3rd Generation Dual-Source CT System: Diagnostic Performance and Potential for Reduction in Radiation Dose and Contrast Material Requirement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coronary CT angiography is used to examine the coronary arteries in a non-invasive way when a&#xD;
      patient is suspected of having coronary artery disease. The test, however, requires&#xD;
      relatively high levels of radiation, which have been linked to DNA damage and cancer, and the&#xD;
      use of contrast material, which can affect kidney function. The SOMATOM Force, a new&#xD;
      third-generation CT scanner manufactured by Siemens, was recently installed at MUSC and holds&#xD;
      the potential to obtain quality images while also reducing radiation dose and contrast&#xD;
      material. This study aims to test the diagnostic ability of the SOMATOM Force in detecting&#xD;
      coronary artery disease and also see if radiation dose and contrast material are reduced&#xD;
      compared to the previous 2nd generation scanners. It is suspected that the Force will provide&#xD;
      clinical quality images while decreasing radiation dose and contrast material required.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiation dose and contrast material</measure>
    <time_frame>one year</time_frame>
    <description>To determine the potential for reductions in radiation dose and contrast material requirements by performing coronary CT angiography at low tube potential with the new CT system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic accuracy</measure>
    <time_frame>one year</time_frame>
    <description>To determine the diagnostic accuracy of coronary CT angiography performed with the new CT system using coronary catheterization or nuclear myocardial perfusion imaging as reference standards.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Force</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving coronary CT angiography on the SOMATOM Force before clinically indicated cardiac catheterization or after clinically indicated nuclear stress test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients who have already received comparable CT examinations on current routine 2nd generation dual-source CT systems</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Coronary CT angiography on SOMATOM Force</intervention_name>
    <description>Coronary CT angiography using iodinated contrast; metoprolol and/or nitroglycerin may also be administered on a per-patient basis</description>
    <arm_group_label>Force</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Previous coronary CT angiography on 2nd generation CT scanner</intervention_name>
    <description>Clinically indicated coronary CT angiography previously performed on a 2nd generation CT scanner</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be between 18-90 years of age.&#xD;
&#xD;
          -  Subject must have been referred for a clinically indicated cardiac catheterization or&#xD;
             nuclear cardiac perfusion study.&#xD;
&#xD;
          -  Subject must provide written informed consent prior to any study-related procedures&#xD;
             being performed.&#xD;
&#xD;
          -  Subject must be willing to comply with all clinical study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:&#xD;
&#xD;
               -  By testing (urine βHCG) within 24 hours before contrast agent administration, or&#xD;
&#xD;
               -  By surgical sterilization, or&#xD;
&#xD;
               -  Post menopausal, with minimum one (1) year history without menses.&#xD;
&#xD;
          -  Subject has an acute psychiatric disorder or is cognitively impaired.&#xD;
&#xD;
          -  Subject is using or is dependent on substances of abuse.&#xD;
&#xD;
          -  Subject is unwilling to comply with the requirements of the protocol.&#xD;
&#xD;
          -  Subject has decreased renal function (eGFR &lt;45)&#xD;
&#xD;
          -  Subject has an allergy against iodinated contrast agents.&#xD;
&#xD;
          -  Subject is in acute unstable condition.&#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_official>
    <last_name>U. Joseph Schoepf, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MUSC Ashley River Tower</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>April 30, 2018</last_update_submitted>
  <last_update_submitted_qc>April 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>U. Joseph Schoepf, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</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/NCT02218060
org study id: Force Cardiac
nct id: NCT02218060
lead sponsor: 
has dmc: No
Coronary CT angiography is used to examine the coronary arteries in a non-invasive way when a
      patient is suspected of having coronary artery disease. The test, however, requires
      relatively high levels of radiation, which have been linked to DNA damage and cancer, and the
      use of contrast material, which can affect kidney function. The SOMATOM Force, a new
      third-generation CT scanner manufactured by Siemens, was recently installed at MUSC and holds
      the potential to obtain quality images while also reducing radiation dose and contrast
      material. This study aims to test the diagnostic ability of the SOMATOM Force in detecting
      coronary artery disease and also see if radiation dose and contrast material are reduced
      compared to the previous 2nd generation scanners. It is suspected that the Force will provide
      clinical quality images while decreasing radiation dose and contrast material required.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Radiation dose and contrast material
time frame: one year
description: To determine the potential for reductions in radiation dose and contrast material requirements by performing coronary CT angiography at low tube potential with the new CT system.
measure: Diagnostic accuracy
time frame: one year
description: To determine the diagnostic accuracy of coronary CT angiography performed with the new CT system using coronary catheterization or nuclear myocardial perfusion imaging as reference standards.
arm group label: Force
arm group type: Experimental
description: Patients receiving coronary CT angiography on the SOMATOM Force before clinically indicated cardiac catheterization or after clinically indicated nuclear stress test
arm group label: Control
arm group type: Other
description: Patients who have already received comparable CT examinations on current routine 2nd generation dual-source CT systems
intervention type: Procedure
intervention name: Coronary CT angiography on SOMATOM Force
description: Coronary CT angiography using iodinated contrast; metoprolol and/or nitroglycerin may also be administered on a per-patient basis
arm group label: Force
intervention type: Procedure
intervention name: Previous coronary CT angiography on 2nd generation CT scanner
description: Clinically indicated coronary CT angiography previously performed on a 2nd generation CT scanner
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: U. Joseph Schoepf, MD
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: U. Joseph Schoepf, MD
investigator title: Professor
mesh term: Coronary Artery Disease