<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/NCT02265146</url>
  </required_header>
  <id_info>
    <org_study_id>STU 112013-073</org_study_id>
    <nct_id>NCT02265146</nct_id>
  </id_info>
  <brief_title>ORACLE-NIRS: Lipid cORe Plaque Association With CLinical Events: a Near-InfraRed Spectroscopy Study</brief_title>
  <acronym>ORACLE-NIRS</acronym>
  <official_title>Association of Lipid Core Plaque With Subsequent Clinical Outcomes: a Collaborative Near-infrared Spectroscopy Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center, investigator initiated study that will prospectively examine&#xD;
      treatment strategies and outcomes of patients who underwent clinically-indicated Near&#xD;
      Infrared Spectroscopy (NIRS). The information collected will be used to determine the&#xD;
      frequency of NIRS imaging performed at the participating sites and to examine the clinical&#xD;
      outcomes of the NIRS-detected Lipid Core Plaques (LCPs).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    0&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2030</completion_date>
  <primary_completion_date type="Anticipated">December 2030</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>15 Years</target_duration>
  <primary_outcome>
    <measure>Incidence of major adverse cardiac events</measure>
    <time_frame>1 to 15 years following clinically indicated Near InfraRed Spectroscopy imaging</time_frame>
    <description>The primary endpoint for both hypotheses is the incidence of major adverse cardiac events. Major adverse cardiac events include the following:&#xD;
cardiac death&#xD;
cardiac arrest&#xD;
acute coronary syndrome&#xD;
stent thrombosis, repeat coronary angiography&#xD;
coronary revascularization (either by percutaneous coronary intervention or coronary artery bypass graft surgery).&#xD;
rehospitalization for progressive angina, attributed to a non-culprit lesion secondary to significant fixed, non-reversible (not-spasm related) lesion progression of more than 20% from the baseline study (confirmed by either serial angiography or by necropsy).&#xD;
Events will be classified as events occurring at the site of stent implantation and events occurring at previously untreated lesions. Moreover, analyses will be performed on a per patient and per LCP basis.</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Coronary Atherosclerosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing clinically-indicated Near Infrared Spectroscopy (NIRS) among various&#xD;
        participating centers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Patients who have undergone/ will be undergoing NIRS imaging at each of the&#xD;
        participating centers.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emmanouil S Brilakis, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>North Florida/(South Georgia) VA Health Care System</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta VA Medical Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jesse Brown VA Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis VA Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA North Texas Health Care System</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>January 16, 2019</last_update_submitted>
  <last_update_submitted_qc>January 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lipid Core Plaques (LCPs)</keyword>
  <keyword>Vulnerable Plaque</keyword>
  <keyword>Near Infrared Spectroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_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/NCT02265146
org study id: STU 112013-073
nct id: NCT02265146
lead sponsor: 
has dmc: No
This is a multi-center, investigator initiated study that will prospectively examine
      treatment strategies and outcomes of patients who underwent clinically-indicated Near
      Infrared Spectroscopy (NIRS). The information collected will be used to determine the
      frequency of NIRS imaging performed at the participating sites and to examine the clinical
      outcomes of the NIRS-detected Lipid Core Plaques (LCPs).
observational model: Cohort
time perspective: Prospective
measure: Incidence of major adverse cardiac events
time frame: 1 to 15 years following clinically indicated Near InfraRed Spectroscopy imaging
description: The primary endpoint for both hypotheses is the incidence of major adverse cardiac events. Major adverse cardiac events include the following:
cardiac death
cardiac arrest
acute coronary syndrome
stent thrombosis, repeat coronary angiography
coronary revascularization (either by percutaneous coronary intervention or coronary artery bypass graft surgery).
rehospitalization for progressive angina, attributed to a non-culprit lesion secondary to significant fixed, non-reversible (not-spasm related) lesion progression of more than 20% from the baseline study (confirmed by either serial angiography or by necropsy).
Events will be classified as events occurring at the site of stent implantation and events occurring at previously untreated lesions. Moreover, analyses will be performed on a per patient and per LCP basis.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Emmanouil S Brilakis, MD, PhD
role: Principal Investigator
affiliation: UT Southwestern Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Atherosclerosis
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia