<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/NCT02985931</url>
  </required_header>
  <id_info>
    <org_study_id>101-0453A3</org_study_id>
    <nct_id>NCT02985931</nct_id>
  </id_info>
  <brief_title>Single-scan Rest/Stress Imaging With Cadmium Zinc Telluride-based SPECT for Coronary Flow Quantification</brief_title>
  <official_title>Single-scan Rest/Stress Imaging With Cadmium Zinc Telluride-based SPECT for Coronary Flow Quantification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim to address this issue with novel image quantification methods using&#xD;
      CZT-based SPECT, which is capable of dynamic data acquisition and therefore feasible for the&#xD;
      quantification of the coronary flow. The investigators will use kinetic modeling techniques&#xD;
      to design a study that allows the absolute flow quantification. To make this study practical,&#xD;
      the investigators will develop a protocol that includes the acquisition of both the rest and&#xD;
      stress scan within the same scan that is shorter than 30 minutes. The SPECT-measured flow&#xD;
      will be validated against the flow measured with cardiac MRI scans. Patients with high CAD&#xD;
      risk will be recruited for the clinical trial. Data from these human subjects will be used&#xD;
      for determination of the performance of the developed algorithm. With the proposed rapid scan&#xD;
      with absolute quantification capabilities, the investigators expect to increase the diagnosis&#xD;
      accuracy while maintaining the patient throughput.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Correlation between SPECT- and MRI-measured flow values</measure>
    <time_frame>through study completion, an average of 3 year</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Quantitative Analysis of SPECT MPI</condition>
  <arm_group>
    <arm_group_label>Suspected CAD subjects</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diagnostic imaging scans of SPECT and MRI</intervention_name>
    <arm_group_label>Suspected CAD subjects</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who are suspected with coronary artery diseases and need imaging exams.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects with high possibility of coronary artery disease after being evaluated by a&#xD;
             cardiologist.&#xD;
&#xD;
          2. &gt; 20 years old.&#xD;
&#xD;
          3. Not under infection or other conditions inappropriate for being recruited.&#xD;
&#xD;
          4. Without myocardial infarction within one week.&#xD;
&#xD;
          5. With stable blood pressure.&#xD;
&#xD;
          6. Subjects with normal kidney functions and without allergic reactions to MRI contrast&#xD;
             agents.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who cannot take a SPECT scan or do not agree to sign the informed consent.&#xD;
&#xD;
          2. Pregnant subjects or subjects who are currently breast-feeding.&#xD;
&#xD;
          3. Those currently under radiation therapies.&#xD;
&#xD;
          4. Patients with pleural effusion.&#xD;
&#xD;
          5. Patients who are allergic to SPECT tracers.&#xD;
&#xD;
          6. Patients with serious psychological disorders.&#xD;
&#xD;
          7. Patients with asthma.&#xD;
&#xD;
          8. Patients with stroke within a week.&#xD;
&#xD;
          9. Patients with AV block.&#xD;
&#xD;
         10. Patients with sinus syndrome.&#xD;
&#xD;
         11. Subjects who are currently under other clinical trials.&#xD;
&#xD;
         12. Subjects with poor kidney functions who are inappropriate for MRI contrast agents.&#xD;
&#xD;
         13. Subjects with pacemakers.&#xD;
&#xD;
         14. Subjects with Claustrophobia.&#xD;
&#xD;
         15. Subjects who cannot hold breath for cardiac MRI studies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tzu-Chen Yen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 4, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 4, 2016</last_update_submitted>
  <last_update_submitted_qc>December 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Tzu-Chen Yen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT02985931
org study id: 101-0453A3
nct id: NCT02985931
lead sponsor: 
has dmc: No
The investigators aim to address this issue with novel image quantification methods using
      CZT-based SPECT, which is capable of dynamic data acquisition and therefore feasible for the
      quantification of the coronary flow. The investigators will use kinetic modeling techniques
      to design a study that allows the absolute flow quantification. To make this study practical,
      the investigators will develop a protocol that includes the acquisition of both the rest and
      stress scan within the same scan that is shorter than 30 minutes. The SPECT-measured flow
      will be validated against the flow measured with cardiac MRI scans. Patients with high CAD
      risk will be recruited for the clinical trial. Data from these human subjects will be used
      for determination of the performance of the developed algorithm. With the proposed rapid scan
      with absolute quantification capabilities, the investigators expect to increase the diagnosis
      accuracy while maintaining the patient throughput.
observational model: Cohort
time perspective: Prospective
measure: Correlation between SPECT- and MRI-measured flow values
time frame: through study completion, an average of 3 year
arm group label: Suspected CAD subjects
intervention type: Other
intervention name: Diagnostic imaging scans of SPECT and MRI
arm group label: Suspected CAD subjects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Tzu-Chen Yen, MD, PhD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Tzu-Chen Yen
investigator title: Professor