<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/NCT03803020</url>
  </required_header>
  <id_info>
    <org_study_id>SHDC12018X05</org_study_id>
    <nct_id>NCT03803020</nct_id>
  </id_info>
  <brief_title>The Evaluation of Fractional Flow Reserve and D SPECT for the Intervention of Chronic Total Occlusion</brief_title>
  <official_title>The Evaluation of Fractional Flow Reserve and D SPECT for the Intervention of Chronic Total Occlusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coronary chronic total occlusions (CTOs) are defined as an occluded coronary vessel with TIMI&#xD;
      defined as an occluded coronary vessel with TIMI (Thrombolysis in Myocardial Infarction)&#xD;
      grade flow 0 and an estimated duration of at least 3 months. They are frequently encountered&#xD;
      in patients undergoing coronary angiography. The application of contemporary techniques and&#xD;
      the use of advanced dedicated equipment lead to high procedural success and low adverse&#xD;
      events rates in experienced centers. Fractional flow reserve (FFR) is a validated tool to&#xD;
      assess physiological severity of coronary artery disease and have a prognostic role after&#xD;
      percutaneous coronary intervention (PCI). SPECT (Single-Photon Emission Computed Tomography)&#xD;
      is the golden standard for detection of myocardial ischemia. Recanalization of a CTO leads to&#xD;
      a number of anatomical and pathophysiological changes to the coronary circulation. These&#xD;
      include anatomical and functional collateral vessels regression and significant lumen&#xD;
      enlargement because of recovery of blood flow and restoration of vasomotor tone. The effect&#xD;
      of PCI on CTO is unknown. The aim of this study was to assess the functional result of CTO&#xD;
      PCI by measuring FFR and D SPECT before and immediately post-CTO PCI and at short-term&#xD;
      follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronary chronic total occlusions (CTOs) are defined as an occluded coronary vessel with TIMI&#xD;
      defined as an occluded coronary vessel with TIMI (Thrombolysis in Myocardial Infarction)&#xD;
      grade flow 0 and an estimated duration of at least 3 months. They are frequently encountered&#xD;
      in patients undergoing coronary angiography. The application of contemporary techniques and&#xD;
      the use of advanced dedicated equipment lead to high procedural success and low adverse&#xD;
      events rates in experienced centers. Fractional flow reserve (FFR) is a validated tool to&#xD;
      assess physiological severity of coronary artery disease and have a prognostic role after&#xD;
      percutaneous coronary intervention (PCI). SPECT (Single-Photon Emission Computed Tomography)&#xD;
      is the golden standard for detection of myocardial ischemia. Recanalization of a CTO leads to&#xD;
      a number of anatomical and pathophysiological changes to the coronary circulation. These&#xD;
      include anatomical and functional collateral vessels regression and significant lumen&#xD;
      enlargement because of recovery of blood flow and restoration of vasomotor tone. The effect&#xD;
      of PCI on CTO is unknown. The aim of this study was to assess the functional result of CTO&#xD;
      PCI by measuring FFR and D SPECT before and immediately post-CTO PCI and at short-term&#xD;
      follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>score of Seattle angina questionnaire</measure>
    <time_frame>one year</time_frame>
    <description>the result of Seattle angina questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>socre of Self-Rating Anxiety Scale</measure>
    <time_frame>one year</time_frame>
    <description>result of socre of Self-Rating Anxiety Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>socre of EuroQol five dimensions questionnaire</measure>
    <time_frame>one year</time_frame>
    <description>result of EuroQol five dimensions questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up</measure>
    <time_frame>one year</time_frame>
    <description>Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the success rate of Percutaneous Coronary Intervention</measure>
    <time_frame>one year</time_frame>
    <description>the success rate of Percutaneous Coronary Intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>rate of cardiac death rate</measure>
    <time_frame>one year</time_frame>
    <description>rate of cardiac death rate in one year recorded in follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of target vessel revascularization rate</measure>
    <time_frame>one year</time_frame>
    <description>rate of target vessel revascularization rate in one year recorded in follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of recurrent myocardial infarction rate</measure>
    <time_frame>one year</time_frame>
    <description>rate of recurrent myocardial infarction rate in one year recorded in follow-up</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>single coronary chronic total occlusion</arm_group_label>
    <description>symptomatic stable angina of single coronary chronic total occlusion without other coronary artery stenosis scheduled for elective PCI.&#xD;
fractional flow reserve and SPECT detection before and after intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fractional flow reserve and SPECT detection</intervention_name>
    <description>fractional flow reserve and SPECT detection</description>
    <arm_group_label>single coronary chronic total occlusion</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients of single coronary chronic total occlusion&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;18 years old&#xD;
&#xD;
          -  single CTO lesions, or other stenosis have been PCI treated for more than one months&#xD;
&#xD;
          -  the diameter of target vessel ≥2.5mm&#xD;
&#xD;
          -  stable angina pectoris, or myocardial ischemia in the area of CTO lesions&#xD;
&#xD;
          -  the patients agree to this research plan and sign the consent form, and complete the&#xD;
             follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute myocardial infarction in one month&#xD;
&#xD;
          -  In addition to the area of CTO lesions, there are serious untreated coronary lesions&#xD;
&#xD;
          -  bridge vascular CTO lesions&#xD;
&#xD;
          -  untreated coronary artery or cardiac surgery due to interventional complications, or&#xD;
             intraoperative death&#xD;
&#xD;
          -  acute decompensated heart failure&#xD;
&#xD;
          -  allergies to contrast or radionuclide tracers&#xD;
&#xD;
          -  patients with planned pregnancies or lactation or 1 years after intervention&#xD;
&#xD;
          -  malignant neoplasms or life expectancy of less than 1 years&#xD;
&#xD;
          -  patients plan of surgery&#xD;
&#xD;
          -  patients cannot tolerate double antiplatelet therapy for at least 12 months&#xD;
&#xD;
          -  any condition that does not fit coronary intervention or is a drug-eluting stent&#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>Jianying Ma, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiology, Zhongshan Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shufu chang, Doctor</last_name>
    <phone>+8618616881731</phone>
    <email>chang.shufu@zs-hospital.sh.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shufu chang, Doctor</last_name>
    <phone>+18616881731</phone>
    <email>chang.shufu@zs-hospital.sh.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zhongshan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>junbo Ge, Doctor</last_name>
      <phone>+86-21-64041990</phone>
      <email>jbge@zs-hospital.sh.cn</email>
    </contact>
    <contact_backup>
      <last_name>jianying Ma, Doctor</last_name>
      <phone>+8618616881653</phone>
      <email>ma.jianying@zs-hospital.sh.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Shufu Chang, doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rende Xu, doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Qing Qin, doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>coronary artery disease</keyword>
  <keyword>chronic total occlusion</keyword>
  <keyword>fractional flow reserve</keyword>
  <keyword>single-photon emission computed tomography</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>Coronary Disease</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/NCT03803020
org study id: SHDC12018X05
nct id: NCT03803020
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Coronary chronic total occlusions (CTOs) are defined as an occluded coronary vessel with TIMI
      defined as an occluded coronary vessel with TIMI (Thrombolysis in Myocardial Infarction)
      grade flow 0 and an estimated duration of at least 3 months. They are frequently encountered
      in patients undergoing coronary angiography. The application of contemporary techniques and
      the use of advanced dedicated equipment lead to high procedural success and low adverse
      events rates in experienced centers. Fractional flow reserve (FFR) is a validated tool to
      assess physiological severity of coronary artery disease and have a prognostic role after
      percutaneous coronary intervention (PCI). SPECT (Single-Photon Emission Computed Tomography)
      is the golden standard for detection of myocardial ischemia. Recanalization of a CTO leads to
      a number of anatomical and pathophysiological changes to the coronary circulation. These
      include anatomical and functional collateral vessels regression and significant lumen
      enlargement because of recovery of blood flow and restoration of vasomotor tone. The effect
      of PCI on CTO is unknown. The aim of this study was to assess the functional result of CTO
      PCI by measuring FFR and D SPECT before and immediately post-CTO PCI and at short-term
      follow-up.
Coronary chronic total occlusions (CTOs) are defined as an occluded coronary vessel with TIMI
      defined as an occluded coronary vessel with TIMI (Thrombolysis in Myocardial Infarction)
      grade flow 0 and an estimated duration of at least 3 months. They are frequently encountered
      in patients undergoing coronary angiography. The application of contemporary techniques and
      the use of advanced dedicated equipment lead to high procedural success and low adverse
      events rates in experienced centers. Fractional flow reserve (FFR) is a validated tool to
      assess physiological severity of coronary artery disease and have a prognostic role after
      percutaneous coronary intervention (PCI). SPECT (Single-Photon Emission Computed Tomography)
      is the golden standard for detection of myocardial ischemia. Recanalization of a CTO leads to
      a number of anatomical and pathophysiological changes to the coronary circulation. These
      include anatomical and functional collateral vessels regression and significant lumen
      enlargement because of recovery of blood flow and restoration of vasomotor tone. The effect
      of PCI on CTO is unknown. The aim of this study was to assess the functional result of CTO
      PCI by measuring FFR and D SPECT before and immediately post-CTO PCI and at short-term
      follow-up.
observational model: Case-Only
time perspective: Prospective
measure: score of Seattle angina questionnaire
time frame: one year
description: the result of Seattle angina questionnaire
measure: socre of Self-Rating Anxiety Scale
time frame: one year
description: result of socre of Self-Rating Anxiety Scale
measure: socre of EuroQol five dimensions questionnaire
time frame: one year
description: result of EuroQol five dimensions questionnaire
measure: Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up
time frame: one year
description: Composite of cardiac death, target vessel myocardial infarction and target lesion revascularization record in follow-up
measure: the success rate of Percutaneous Coronary Intervention
time frame: one year
description: the success rate of Percutaneous Coronary Intervention
measure: rate of cardiac death rate
time frame: one year
description: rate of cardiac death rate in one year recorded in follow-up
measure: rate of target vessel revascularization rate
time frame: one year
description: rate of target vessel revascularization rate in one year recorded in follow-up
measure: rate of recurrent myocardial infarction rate
time frame: one year
description: rate of recurrent myocardial infarction rate in one year recorded in follow-up
arm group label: single coronary chronic total occlusion
description: symptomatic stable angina of single coronary chronic total occlusion without other coronary artery stenosis scheduled for elective PCI.
fractional flow reserve and SPECT detection before and after intervention.
intervention type: Other
intervention name: fractional flow reserve and SPECT detection
description: fractional flow reserve and SPECT detection
arm group label: single coronary chronic total occlusion
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jianying Ma, Doctor
role: Principal Investigator
affiliation: Department of Cardiology, Zhongshan Hospital
last name: Shufu chang, Doctor
phone: +8618616881731
email: chang.shufu@zs-hospital.sh.cn
last name: Shufu chang, Doctor
phone: +18616881731
email: chang.shufu@zs-hospital.sh.cn
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: No