<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/NCT01665248</url>
  </required_header>
  <id_info>
    <org_study_id>AMCCV2012-03</org_study_id>
    <nct_id>NCT01665248</nct_id>
  </id_info>
  <brief_title>Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina</brief_title>
  <official_title>Comparison of 18-F Sodium Fluoride Uptake in Culprit Plaques Between Acute Coronary Syndrome and Stable Angina</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHEOL WHAN LEE, MD, PhD.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CardioVascular Research Foundation, Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the correlations between active calcification and&#xD;
      vulnerable plaque.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Standardized 18F-NaF uptake value within the culprit plaque</measure>
    <time_frame>At the time of diagnosis</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The relationship between 18F-NaF uptake value and calcium scores by Multidetector Computed Tomography</measure>
    <time_frame>at the time of diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relationship between 18F-NaF uptake value and plaque types by Multidetector Computed Tomography</measure>
    <time_frame>at the time of diagnosis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relationship between 18F-NaF uptake value and biomarkers</measure>
    <time_frame>at the time of diagnosis</time_frame>
    <description>hs-CRP, Troponin-I</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The relationship between 18F-NaF uptake value and invasive imagings</measure>
    <time_frame>at the time of diagnosis</time_frame>
    <description>Intravascular ultrasound, Optical coherence tomography</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Coronary Artery Diseases</condition>
  <arm_group>
    <arm_group_label>stable angina pectoris or acute coronary syndrome</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>18-F Sodium Fluoride Uptake in Positron emission tomography</intervention_name>
    <arm_group_label>stable angina pectoris or acute coronary syndrome</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age more than 20&#xD;
&#xD;
          -  Acute coronary syndrome or stable angina&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to the use of heparin, aspirin, clopidogrel, stainless metal,&#xD;
             contrast media&#xD;
&#xD;
          -  Acute ST segment elevation myocardial infarction within 12hours, heart failure,&#xD;
             cardiac shock&#xD;
&#xD;
          -  Any serious medical comorbidity such that the subject's life expectancy is less than&#xD;
             24 months&#xD;
&#xD;
          -  Ejection fraction less than 30&#xD;
&#xD;
          -  Serum creatinine level of 1.5mg/dl and over&#xD;
&#xD;
          -  Vasculitis&#xD;
&#xD;
          -  Unwillingness or inability to cooperate or to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cheol Whan Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>July 25, 2014</last_update_submitted>
  <last_update_submitted_qc>July 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>CardioVascular Research Foundation, Korea</investigator_affiliation>
    <investigator_full_name>CHEOL WHAN LEE, MD, PhD.</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>18-F Sodium Fluoride</keyword>
  <keyword>Acute coronary syndrome</keyword>
  <keyword>Stable Angina</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Angina, Stable</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Listerine</mesh_term>
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Sodium Fluoride</mesh_term>
  </intervention_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/NCT01665248
org study id: AMCCV2012-03
nct id: NCT01665248
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the correlations between active calcification and
      vulnerable plaque.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Standardized 18F-NaF uptake value within the culprit plaque
time frame: At the time of diagnosis
measure: The relationship between 18F-NaF uptake value and calcium scores by Multidetector Computed Tomography
time frame: at the time of diagnosis
measure: The relationship between 18F-NaF uptake value and plaque types by Multidetector Computed Tomography
time frame: at the time of diagnosis
measure: The relationship between 18F-NaF uptake value and biomarkers
time frame: at the time of diagnosis
description: hs-CRP, Troponin-I
measure: The relationship between 18F-NaF uptake value and invasive imagings
time frame: at the time of diagnosis
description: Intravascular ultrasound, Optical coherence tomography
arm group label: stable angina pectoris or acute coronary syndrome
arm group type: Other
intervention type: Other
intervention name: 18-F Sodium Fluoride Uptake in Positron emission tomography
arm group label: stable angina pectoris or acute coronary syndrome
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Cheol Whan Lee, MD, PhD
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: CardioVascular Research Foundation, Korea
investigator full name: CHEOL WHAN LEE, MD, PhD.
investigator title: MD, PhD
mesh term: Coronary Artery Disease
mesh term: Acute Coronary Syndrome
mesh term: Angina, Stable
mesh term: Listerine
mesh term: Fluorides
mesh term: Sodium Fluoride