<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/NCT02245048</url>
  </required_header>
  <id_info>
    <org_study_id>13-008535</org_study_id>
    <nct_id>NCT02245048</nct_id>
  </id_info>
  <brief_title>CIMT and Plaque Assessment Findings in Subjects Undergoing Stress Echocardiography For Risk Stratification</brief_title>
  <official_title>Carotid Intima-Media Thickness and Plaque Assessment Findings in Subjects Undergoing Stress Echocardiography For Risk Stratification</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Esaote North America</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to determine if carotid artery ultrasound scanning can&#xD;
      provide additional information for determining cardiovascular risk in patients.&#xD;
&#xD;
      Patients who agree to participate wil undergo non-invasive carotid intima-media thickness&#xD;
      (CIMT) measurement and plaque assessment. Findings of CIMT will be compared to results of&#xD;
      patient standard of care stress echocardiogram (SE) and of diastolic function.&#xD;
&#xD;
      We hypothesize tht 1) in patients undergoing SE for inappropriate or uncertain indications,&#xD;
      CIMT and plaque assessment will provide useful risk stratification beyond use of traditional&#xD;
      risk factors; 2) CIMT findings will correlate with results of SE in terms of exercise&#xD;
      capacity and 3) Exercise capacity will correlate with diastolic function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>% Patients w/ Abnormal IMT vs. % Patients w/ Positive Ischemia on Stress Echocardiogram</measure>
    <time_frame>Baseline</time_frame>
    <description>We are comparing the % of patients with abnormal IMT defined as presence of plaque (= or &gt;1.5mm) or CIMT &gt;75% percentile for age, race, and gender compared to % of patients with positive ischemia on stress echocardiogram as defined by a new wall motion abnormality on echocardiogram with stress.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">73</enrollment>
  <condition>Cardiovascular Risk Stratification</condition>
  <condition>Carotid Intima-media Thickness (CIMT)</condition>
  <condition>Stress Echocardiography (SE)</condition>
  <arm_group>
    <arm_group_label>Stress Echocardiography (SE)</arm_group_label>
    <description>Subjects will undergo CIMT measurements.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Carotid Intima-Media Thickness (CIMT)</intervention_name>
    <arm_group_label>Stress Echocardiography (SE)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible patients will be undergoing standard of care stress echocardiography&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Asymptomatic&#xD;
&#xD;
          -  No prior cardiac history (MI, PTCA, CABG, angina)&#xD;
&#xD;
          -  No peripheral vascular disease&#xD;
&#xD;
          -  No history of stroke or TIA&#xD;
&#xD;
          -  Statins, antihypertensives, ASA treatment OK&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of CAD, CABG, PTCA, coronary or peripheral stenting&#xD;
&#xD;
          -  History of stroke/TIA/peripheral vascular disease&#xD;
&#xD;
          -  Inability to exercise on the treadmill&#xD;
&#xD;
          -  Unwilling/unable to sign informed consent&#xD;
&#xD;
          -  History of neck radiation or neck surgery or inability to obtain neck images&#xD;
&#xD;
          -  End stage renal disease&#xD;
&#xD;
          -  Preoperative evaluation&#xD;
&#xD;
          -  History of chest pain&#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>Tasneem Naqvi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85254</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>May 1, 2023</last_update_submitted>
  <last_update_submitted_qc>May 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Tasneem Z. Naqvi, M.D.</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>Cardiovascular Risk Stratification</keyword>
  <keyword>Carotid intima-media thickness (CIMT)</keyword>
  <keyword>Stress echocardiography (SE)</keyword>
  <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/NCT02245048
org study id: 13-008535
nct id: NCT02245048
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this research study is to determine if carotid artery ultrasound scanning can
      provide additional information for determining cardiovascular risk in patients.

      Patients who agree to participate wil undergo non-invasive carotid intima-media thickness
      (CIMT) measurement and plaque assessment. Findings of CIMT will be compared to results of
      patient standard of care stress echocardiogram (SE) and of diastolic function.

      We hypothesize tht 1) in patients undergoing SE for inappropriate or uncertain indications,
      CIMT and plaque assessment will provide useful risk stratification beyond use of traditional
      risk factors; 2) CIMT findings will correlate with results of SE in terms of exercise
      capacity and 3) Exercise capacity will correlate with diastolic function.
observational model: Cohort
time perspective: Prospective
measure: % Patients w/ Abnormal IMT vs. % Patients w/ Positive Ischemia on Stress Echocardiogram
time frame: Baseline
description: We are comparing the % of patients with abnormal IMT defined as presence of plaque (= or >1.5mm) or CIMT >75% percentile for age, race, and gender compared to % of patients with positive ischemia on stress echocardiogram as defined by a new wall motion abnormality on echocardiogram with stress.
arm group label: Stress Echocardiography (SE)
description: Subjects will undergo CIMT measurements.
intervention type: Other
intervention name: Carotid Intima-Media Thickness (CIMT)
arm group label: Stress Echocardiography (SE)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tasneem Naqvi, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Tasneem Z. Naqvi, M.D.
investigator title: PI
sharing ipd: No