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/NCT06030596</url>
    </required_header>
    <id_info>
      <org_study_id>SPECT MBFQ Trial II</org_study_id>
      <nct_id>NCT06030596</nct_id>
    </id_info>
    <brief_title>SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve</brief_title>
    <official_title>SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China National Center for Cardiovascular Diseases</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China National Center for Cardiovascular Diseases</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Recent evidences have demonstrated improved diagnostic accuracy for detecting coronary artery&#xD;
        disease (CAD) when myocardial blood flow (MBF) is quantified in absolute terms using single&#xD;
        photon emission tomography (SPECT) compared to conventional myocardial perfusion imaging&#xD;
        (MPI). However, there are no uniformly accepted cutoff values of MBF and MFR derived from&#xD;
        SPECT for diagnosing hemodynamically significant CAD. Particularly, the diagnostic&#xD;
        performance for quantitative SPECT has not been validated using fractional flow reserve&#xD;
        (FFR). The aim of this prospective study is to determine optimal cutoff values of absolute&#xD;
        MBF and MFR derived from NaI (Tl)-based SPECT and to evaluate the diagnostic efficacy of this&#xD;
        quantitative technology utilizing invasive coronary angiography (ICA) in combination with FFR&#xD;
        results as the reference standard in patients with suspected or known CAD.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 9, 2022</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>The diagnostic accuracy of MBF and MFR derived from SPECT</measure>
      <time_frame>1 year</time_frame>
      <description>The diagnostic sensitivity, specificity, accuracy of MBF and MFR derived from SPECT for the detection of hemodynamically significant coronary artery disease as defined by invasive coronary angiography in combination with fractional flow reserve measurements.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">210</enrollment>
    <condition>Coronary Artery Disease</condition>
    <arm_group>
      <arm_group_label>coronary artery disease</arm_group_label>
      <description>Suspected or known coronary artery disease</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Suspected or known CAD&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 ~ 79 years old&#xD;
  &#xD;
            -  At least one CAD risk factor&#xD;
  &#xD;
            -  Intermediate to high pre-test likelihood for CAD&#xD;
  &#xD;
            -  Suspected or known CAD, clinically referred for invasive coronary angiography&#xD;
  &#xD;
            -  Able and willing to comply with the study procedures&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History or risk of severe bradycardia&#xD;
  &#xD;
            -  History of myocardial infarction, dilated cardiomyopathy, hypertrophic cardiomyopathy,&#xD;
               valve issue or congenital heart disease&#xD;
  &#xD;
            -  Wheezing asthma or COPD&#xD;
  &#xD;
            -  Known second- or third-degree AV block&#xD;
  &#xD;
            -  Known hypersensitivity to dipyridamole or adenosine&#xD;
  &#xD;
            -  Known coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI)&#xD;
               prior to screening&#xD;
  &#xD;
            -  Breastfeeding or pregnancy&#xD;
  &#xD;
            -  Claustrophobia or inability to lie still in a supine position&#xD;
  &#xD;
            -  Unwillingness or inability to provide informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>79 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wei Fang, MD/PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Fuwai Hospital, Beijing, China</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lei Wang, MD/PhD</last_name>
      <phone>861088322728</phone>
      <email>leiwangfw@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fuwai Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100037</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wei Fang, MD/PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>China National Center for Cardiovascular Diseases</investigator_affiliation>
      <investigator_full_name>Wei Fang</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <keyword>SPECT</keyword>
    <keyword>Myocardial Blood Flow</keyword>
    <keyword>Myocardial Flow Reserve</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>Heart Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06030596
  org study id: SPECT MBFQ Trial II
  nct id: NCT06030596
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Recent evidences have demonstrated improved diagnostic accuracy for detecting coronary artery
        disease (CAD) when myocardial blood flow (MBF) is quantified in absolute terms using single
        photon emission tomography (SPECT) compared to conventional myocardial perfusion imaging
        (MPI). However, there are no uniformly accepted cutoff values of MBF and MFR derived from
        SPECT for diagnosing hemodynamically significant CAD. Particularly, the diagnostic
        performance for quantitative SPECT has not been validated using fractional flow reserve
        (FFR). The aim of this prospective study is to determine optimal cutoff values of absolute
        MBF and MFR derived from NaI (Tl)-based SPECT and to evaluate the diagnostic efficacy of this
        quantitative technology utilizing invasive coronary angiography (ICA) in combination with FFR
        results as the reference standard in patients with suspected or known CAD.
  observational model: Cohort
  time perspective: Prospective
  measure: The diagnostic accuracy of MBF and MFR derived from SPECT
  time frame: 1 year
  description: The diagnostic sensitivity, specificity, accuracy of MBF and MFR derived from SPECT for the detection of hemodynamically significant coronary artery disease as defined by invasive coronary angiography in combination with fractional flow reserve measurements.
  arm group label: coronary artery disease
  description: Suspected or known coronary artery disease
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 79 Years
  healthy volunteers: No
  last name: Wei Fang, MD/PhD
  role: Study Chair
  affiliation: Fuwai Hospital, Beijing, China
  last name: Lei Wang, MD/PhD
  phone: 861088322728
  email: leiwangfw@126.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: China National Center for Cardiovascular Diseases
  investigator full name: Wei Fang
  investigator title: MD
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Heart Diseases
  sharing ipd: No