<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/NCT01697995</url>
  </required_header>
  <id_info>
    <org_study_id>REGA-11J08</org_study_id>
    <nct_id>NCT01697995</nct_id>
  </id_info>
  <brief_title>Stress Induced Right Ventricular Uptake on Lexiscan Stress MPI</brief_title>
  <acronym>RVuptakeLexi</acronym>
  <official_title>Diagnostic and Prognostic Value of the Stress Induced Right Ventricular Uptake on Lexiscan Stress MPI in Patients With Known or Suspected Coronary Artery Disease (CAD).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aiden Abidov</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Astellas Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Arizona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to determine the:&#xD;
&#xD;
        1. Diagnostic value of stress induced RV changes on Lexiscan stress MPI as compared to&#xD;
           Exercise stress MPI in predicting a significant CAD.&#xD;
&#xD;
        2. Prognostic value of stress induced RV changes on Lexiscan stress MPI in predicting&#xD;
           adverse short-term and long-term clinical outcomes after the index test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 1: Retrospective data collection/analysis All Lexiscan and exercise MPI images on&#xD;
      patients performed for clinical indications in calendar year 2010 who had subsequent coronary&#xD;
      angiogram within 3 months after index MPI will be retrieved for review by two experts. We&#xD;
      will identify different types of RV uptake and RV overload during stress as well as presence&#xD;
      or absence of these changes on resting images. Analysis will include increased RV uptake,&#xD;
      enlargement, hypertrophy, thinning of RV and flattening of the interventricular septum.&#xD;
      Diagnostic performance (sensitivity, specificity and diagnostic accuracy) of the identified&#xD;
      pathological RV phenotypes in identifying severe and extensive disease will be evaluated by&#xD;
      comparison with contrary angiograms. Comparison of the set of parameters identifying&#xD;
      pathological RV changes, identifying normal and abnormal values of these novel ancillary&#xD;
      markers, as well as assessing their diagnostic accuracy in patients with suspected and known&#xD;
      CAD during vasodilator stress versus exercise stress MPI will be done.&#xD;
&#xD;
      Phase 2: Prospective data validation Patients referred for the Lexiscan stress MPI will be&#xD;
      followed prospectively after obtaining an informed consent. All comers after June 1 2012 will&#xD;
      be included. Prediction of coronary artery disease will be performed by applying the&#xD;
      previously derived pathological RV criteria on the prospective stress MPIs. 2D-Echocardiogram&#xD;
      will be performed for all the patients who do not have an Echocardiogram performed for&#xD;
      clinical indication within 1 month of their index Lexiscan stress MPI. We will also include&#xD;
      100 patients referred for the exercise stress MPI who will serve as controls.&#xD;
&#xD;
      All patients will be prospectively followed up for a total of 12 months for the following&#xD;
      prognostic end points:&#xD;
&#xD;
        1. Hard cardiac events (cardiac death or MI);&#xD;
&#xD;
        2. Total (all-cause) mortality;&#xD;
&#xD;
        3. Cardiovascular hospitalization rate. Cardiac death (CD) will be defined as death&#xD;
           attributable to any cardiac cause (eg, lethal arrhythmia, myocardial infarction [MI], or&#xD;
           pump failure) as confirmed by review of death certificate and medical records.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Hard cardiac events (cardiac death or MI)</measure>
    <time_frame>within 1 year after the index test</time_frame>
    <description>Patient follow-up evaluated for hard cardiac events (cardiac death or MI)in the year post index test determined by telephone interviews or review of medical records</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total (all-cause) mortality</measure>
    <time_frame>within 1 year after the index test</time_frame>
    <description>Total (all-cause) mortality in the year post index test determined by telephone interviews or review of medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular hospitalization rate</measure>
    <time_frame>within 1 year after the index test</time_frame>
    <description>Cardiovascular hospitalization rate in the year post index test determined by telephone interviews or review of medical records</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">650</enrollment>
  <condition>Increased Right Ventricular Radiotracer Uptake</condition>
  <arm_group>
    <arm_group_label>Lexiscan-Echo echo subjects</arm_group_label>
    <description>No Intervention: Observational study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lexiscan-Echo control subjects</arm_group_label>
    <description>No intervention: observational study</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        1. Retrospective population (approximately 300 charts to be reviewed)&#xD;
&#xD;
               -  Patients with MPI and 2D Echocardiogram within one month of the stress testing in&#xD;
                  calendar year 2010 at University Medical Center, Tucson AZ.&#xD;
&#xD;
               -  18 years or older&#xD;
&#xD;
          2. Prospective population (approximately 350 subjects to be recruited)&#xD;
&#xD;
               -  Patients scheduled for MPI at University Medical Center, Tucson AZ, and invited&#xD;
                  to participate in this study.&#xD;
&#xD;
               -  18 years to 89 years old&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Retrospective population (approximately 300 charts to be reviewed)&#xD;
&#xD;
               -  Patients with MPI and 2D Echocardiogram within one month of the stress testing in&#xD;
                  calendar year 2010 at University Medical Center, Tucson AZ.&#xD;
&#xD;
               -  18 years or older.&#xD;
&#xD;
          2. Prospective population (approximately 350 subjects to be recruited)&#xD;
&#xD;
               -  Patients scheduled for MPI at University Medical Center, Tucson AZ.&#xD;
&#xD;
               -  18 years to 89 years old&#xD;
&#xD;
        Exclusion Criteria (applied to both retrospective and prospective arms):&#xD;
&#xD;
          -  patients with nondiagnostic or technically defective MPI&#xD;
&#xD;
          -  incomplete clinical data&#xD;
&#xD;
          -  severe valvular heart disease&#xD;
&#xD;
          -  complex congenital heart disease&#xD;
&#xD;
          -  life expectancy less than one year at the time of the index MPI&#xD;
&#xD;
          -  unable to follow up (absence of permanent address)&#xD;
&#xD;
          -  Known prisoners, pregnant women and cognitively impaired patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aiden Abidov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arizona Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>November 3, 2015</last_update_submitted>
  <last_update_submitted_qc>November 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Arizona</investigator_affiliation>
    <investigator_full_name>Aiden Abidov</investigator_full_name>
    <investigator_title>Associate Professor of Medicine and Radiology</investigator_title>
  </responsible_party>
  <keyword>right ventricle</keyword>
  <keyword>radiotracer uptake</keyword>
  <keyword>Myocardial Perfusion Imaging</keyword>
  <keyword>balanced ischemia</keyword>
  <!-- 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/NCT01697995
org study id: REGA-11J08
nct id: NCT01697995
lead sponsor: 
collaborator: 
has dmc: No
The objectives of this study are to determine the:

        1. Diagnostic value of stress induced RV changes on Lexiscan stress MPI as compared to
           Exercise stress MPI in predicting a significant CAD.

        2. Prognostic value of stress induced RV changes on Lexiscan stress MPI in predicting
           adverse short-term and long-term clinical outcomes after the index test.
Phase 1: Retrospective data collection/analysis All Lexiscan and exercise MPI images on
      patients performed for clinical indications in calendar year 2010 who had subsequent coronary
      angiogram within 3 months after index MPI will be retrieved for review by two experts. We
      will identify different types of RV uptake and RV overload during stress as well as presence
      or absence of these changes on resting images. Analysis will include increased RV uptake,
      enlargement, hypertrophy, thinning of RV and flattening of the interventricular septum.
      Diagnostic performance (sensitivity, specificity and diagnostic accuracy) of the identified
      pathological RV phenotypes in identifying severe and extensive disease will be evaluated by
      comparison with contrary angiograms. Comparison of the set of parameters identifying
      pathological RV changes, identifying normal and abnormal values of these novel ancillary
      markers, as well as assessing their diagnostic accuracy in patients with suspected and known
      CAD during vasodilator stress versus exercise stress MPI will be done.

      Phase 2: Prospective data validation Patients referred for the Lexiscan stress MPI will be
      followed prospectively after obtaining an informed consent. All comers after June 1 2012 will
      be included. Prediction of coronary artery disease will be performed by applying the
      previously derived pathological RV criteria on the prospective stress MPIs. 2D-Echocardiogram
      will be performed for all the patients who do not have an Echocardiogram performed for
      clinical indication within 1 month of their index Lexiscan stress MPI. We will also include
      100 patients referred for the exercise stress MPI who will serve as controls.

      All patients will be prospectively followed up for a total of 12 months for the following
      prognostic end points:

        1. Hard cardiac events (cardiac death or MI);

        2. Total (all-cause) mortality;

        3. Cardiovascular hospitalization rate. Cardiac death (CD) will be defined as death
           attributable to any cardiac cause (eg, lethal arrhythmia, myocardial infarction [MI], or
           pump failure) as confirmed by review of death certificate and medical records.
observational model: Case-Control
measure: Hard cardiac events (cardiac death or MI)
time frame: within 1 year after the index test
description: Patient follow-up evaluated for hard cardiac events (cardiac death or MI)in the year post index test determined by telephone interviews or review of medical records
measure: Total (all-cause) mortality
time frame: within 1 year after the index test
description: Total (all-cause) mortality in the year post index test determined by telephone interviews or review of medical records
measure: Cardiovascular hospitalization rate
time frame: within 1 year after the index test
description: Cardiovascular hospitalization rate in the year post index test determined by telephone interviews or review of medical records
arm group label: Lexiscan-Echo echo subjects
description: No Intervention: Observational study
arm group label: Lexiscan-Echo control subjects
description: No intervention: observational study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aiden Abidov, MD
role: Principal Investigator
affiliation: University of Arizona
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Arizona
investigator full name: Aiden Abidov
investigator title: Associate Professor of Medicine and Radiology