xml: <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/NCT05994014</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00317553</org_study_id>
      <nct_id>NCT05994014</nct_id>
    </id_info>
    <brief_title>PET/CT* vs. Cardiac CT for Detecting Coronary Atherosclerotic Disease [*PET: Positron Emission Tomography; CT: Computed Tomography]</brief_title>
    <acronym>PET; CT</acronym>
    <official_title>PET/CT vs. Cardiac CT for Detecting Coronary Atherosclerotic Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Johns Hopkins University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Johns Hopkins University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Early detection of coronary atherosclerotic disease facilitates adequate prevention. The&#xD;
        purpose of this study is to compare an assessment of coronary atherosclerotic disease burden&#xD;
        by positron emission tomography / computed tomography (NaF-PET/CT) with those of conventional&#xD;
        and ultra-high-resolution-CT (UHR-CT) in patients with suspected coronary artery disease. For&#xD;
        this purpose, the investigators plan to include 33 patients with symptoms concerning for CAD&#xD;
        who have been referred for cardiac CT testing.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Early detection of coronary atherosclerotic disease facilitates adequate prevention. 18&#xD;
        Fluoride (F) -sodium fluoride PET/CT (NaF-PET/ CT) has been shown to detect aortic&#xD;
        microcalcification as early manifestation of atherosclerosis in experimental and early&#xD;
        clinical investigations. The capability of NaF-PET/CT to detect coronary atherosclerotic&#xD;
        disease in humans remains unclear. Given its sensitivity to detect vascular&#xD;
        microcalcification undetectable by conventional CT, NaF-PET/CT may be an attractive,&#xD;
        noninvasive test for early detection of coronary atherosclerosis.&#xD;
  &#xD;
        The purpose of this study is to compare an assessment of coronary atherosclerotic disease&#xD;
        burden by positron emission tomography / computed tomography (NaF-PET/CT) with those of&#xD;
        conventional and ultra-high-resolution-CT (UHR-CT) in patients with suspected coronary artery&#xD;
        disease (CAD). For this purpose, the investigators plan to include 33 patients with symptoms&#xD;
        concerning for CAD who have been referred for cardiac CT testing. In addition to the&#xD;
        clinically indicated and performed cardiac CT scan, participants will be asked to also&#xD;
        undergo NaF-PET/CT for comparison of atherosclerosis assessment among the two tests (single&#xD;
        center, prospective diagnostic accuracy study).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">June 2026</completion_date>
    <primary_completion_date type="Anticipated">June 2026</primary_completion_date>
    <phase>N/A</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>Correlation of atheroma volume [mm3]</measure>
      <time_frame>60 days</time_frame>
      <description>Coronary atheroma volume by PET/CT vs. CT total atheroma volume</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diagnostic accuracy of detecting coronary atherosclerosis</measure>
      <time_frame>60 days</time_frame>
      <description>PET/CT Sensitivity to detect any atherosclerosis by CT angiography</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">33</enrollment>
    <condition>Coronary Artery Disease</condition>
    <condition>Atherosclerosis</condition>
    <condition>Coronary Atherosclerosis of Native Coronary Artery</condition>
    <arm_group>
      <arm_group_label>Main group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All patients undergo both, experimental and standard, tests</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>PET/CT</intervention_name>
      <description>Experimental test for detecting atherosclerosis</description>
      <arm_group_label>Main group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female patients&#xD;
  &#xD;
            -  18 years or older&#xD;
  &#xD;
            -  referred for coronary CT angiography because of suspected coronary heart disease (CHD)&#xD;
               with stable symptoms&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The patient has a history of coronary heart disease, defined by prior myocardial&#xD;
               infarction or prior coronary artery revascularization.&#xD;
  &#xD;
            -  Pregnancy.&#xD;
  &#xD;
            -  Atrial fibrillation.&#xD;
  &#xD;
            -  Morbid obesity defines as a body mass index of &gt;40.&#xD;
  &#xD;
            -  The patient has any other clinically significant medical condition that in the opinion&#xD;
               of the Investigator could impact the patient's ability to successfully complete the&#xD;
               trial.&#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>Armin Zadeh, MD PhD MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Johns Hopkins School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Armin A Zadeh, MD PhD MPH</last_name>
      <phone>410-502-0549</phone>
      <email>azadeh1@jhmi.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tia Thomas, RN, BSN</last_name>
      <phone>410-955-5000</phone>
      <email>tthoma88@jh.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Johns Hopkins Hospital</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>21287</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>President</last_name>
      </contact>
      <investigator>
        <last_name>Armin A Zadeh, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>coronary imaging; prevention; early detection</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
      <mesh_term>Atherosclerosis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994014
  org study id: IRB00317553
  nct id: NCT05994014
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Early detection of coronary atherosclerotic disease facilitates adequate prevention. The
        purpose of this study is to compare an assessment of coronary atherosclerotic disease burden
        by positron emission tomography / computed tomography (NaF-PET/CT) with those of conventional
        and ultra-high-resolution-CT (UHR-CT) in patients with suspected coronary artery disease. For
        this purpose, the investigators plan to include 33 patients with symptoms concerning for CAD
        who have been referred for cardiac CT testing.
  Early detection of coronary atherosclerotic disease facilitates adequate prevention. 18
        Fluoride (F) -sodium fluoride PET/CT (NaF-PET/ CT) has been shown to detect aortic
        microcalcification as early manifestation of atherosclerosis in experimental and early
        clinical investigations. The capability of NaF-PET/CT to detect coronary atherosclerotic
        disease in humans remains unclear. Given its sensitivity to detect vascular
        microcalcification undetectable by conventional CT, NaF-PET/CT may be an attractive,
        noninvasive test for early detection of coronary atherosclerosis.
  
        The purpose of this study is to compare an assessment of coronary atherosclerotic disease
        burden by positron emission tomography / computed tomography (NaF-PET/CT) with those of
        conventional and ultra-high-resolution-CT (UHR-CT) in patients with suspected coronary artery
        disease (CAD). For this purpose, the investigators plan to include 33 patients with symptoms
        concerning for CAD who have been referred for cardiac CT testing. In addition to the
        clinically indicated and performed cardiac CT scan, participants will be asked to also
        undergo NaF-PET/CT for comparison of atherosclerosis assessment among the two tests (single
        center, prospective diagnostic accuracy study).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Correlation of atheroma volume [mm3]
  time frame: 60 days
  description: Coronary atheroma volume by PET/CT vs. CT total atheroma volume
  measure: Diagnostic accuracy of detecting coronary atherosclerosis
  time frame: 60 days
  description: PET/CT Sensitivity to detect any atherosclerosis by CT angiography
  arm group label: Main group
  arm group type: Other
  description: All patients undergo both, experimental and standard, tests
  intervention type: Diagnostic Test
  intervention name: PET/CT
  description: Experimental test for detecting atherosclerosis
  arm group label: Main group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Armin Zadeh, MD PhD MPH
  role: Principal Investigator
  affiliation: Johns Hopkins School of Medicine
  last name: Armin A Zadeh, MD PhD MPH
  phone: 410-502-0549
  email: azadeh1@jhmi.edu
  last name: Tia Thomas, RN, BSN
  phone: 410-955-5000
  email: tthoma88@jh.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Atherosclerosis