<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/NCT01700972</url>
  </required_header>
  <id_info>
    <org_study_id>REGA-12B03</org_study_id>
    <nct_id>NCT01700972</nct_id>
  </id_info>
  <brief_title>Feasibility and Diagnostic Accuracy of Myocardial Perfusion Imaging Using Early Imaging Protocol</brief_title>
  <official_title>Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Astellas Pharma US, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current protocol for myocardial perfusion imaging (MPI) entails imaging within 30-45&#xD;
      minutes after radiotracer injection, for both rest and stress studies. We hypothesize that&#xD;
      early imaging 10 minutes after radiotracer injection provides high image quality and&#xD;
      diagnostic accuracy comparable to 30-45 minutes MPI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current MPI protocol entails imaging within 30-45 minutes after radiotracer injection&#xD;
      (W30 imaging), for both the rest and stress part. This delay between the radiotracer&#xD;
      injection and imaging is intended to limit the nonspecific liver and gut radioactivity to the&#xD;
      heart and allows an optimal imaging of the heart. A recent publication however indicates that&#xD;
      an early imaging within 10 minutes after radiotracer injection (W10 imaging) appears feasible&#xD;
      and may be as good as W30 imaging.&#xD;
&#xD;
      Encouraged by the recent data, we think that a waiting time of 10 minutes is feasible while&#xD;
      preserving the image quality; thus, we would like to assess the feasibility and accuracy of&#xD;
      W10 imaging compared with W30 imaging in this study. The main purpose of this study is to&#xD;
      obtain imaging information on the use of early imaging (W10). The feasibility of W10 imaging&#xD;
      will be assessed visually using a 3-point scale as well as semiquantitatively using&#xD;
      region-of-interest measurements. The accuracy of W10 imaging will be determined by comparing&#xD;
      the findings of W10 with those of coronary angiography, which will be obtained within 30 days&#xD;
      of the MPI and serve as reference standard. The tolerability of W10 will be assessed using&#xD;
      3-point scale Questionnaires.&#xD;
&#xD;
      This study will determine if early MPI imaging within 10 minutes works as well as imaging&#xD;
      after 30-45 minutes waiting and its role in the diagnosis of coronary artery disease. The&#xD;
      major advantages of this new imaging procedure include the shortening of the procedure time,&#xD;
      the reduction of patient discomfort and improvement of patient care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The study did not recruit/no study activity occurred.&#xD;
  </why_stopped>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">August 2014</completion_date>
  <primary_completion_date type="Anticipated">January 2014</primary_completion_date>
  <phase>Phase 4</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>Feasibility and accuracy of early imaging at 10 minutes (W10) vs. standard imaging at 30-45 minute after radiotracer injection</measure>
    <time_frame>30 days</time_frame>
    <description>The feasibility of W10 imaging will be assessed visually using a 3-point scale as well as semiquantitatively using region-of-interest measurements. The accuracy of W10 imaging will be determined by comparing the findings of W10 with those of coronary angiography, which will be obtained within 30 days of the MPI and serve as reference standard.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tolerability of early imaging at 10 minutes (W10)</measure>
    <time_frame>Two hours</time_frame>
    <description>The tolerability of W10 will be assessed using 3-point scale Questionnaires.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Imaging at 10-minute vs. 30-45-minutes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The radionuclide Myoview will be administered once for the rest and stress myocardial perfusion imaging. The subsequent rest and stress imaging will be performed twice each - at 10 minutes and 30-45 minutes after radiotracer injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Myocardial perfusion imaging</intervention_name>
    <description>The radionuclide Myoview will be administered once for the rest and stress myocardial perfusion imaging. The subsequent rest and stress imaging will be performed twice each - at 10 minutes and 30-45 minutes after radiotracer injection.</description>
    <arm_group_label>Imaging at 10-minute vs. 30-45-minutes</arm_group_label>
    <other_name>Myocardial perfusion SPECT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women ≥18 years of age of any race /ethnicity&#xD;
&#xD;
          -  Patient has undergone or is being scheduled for a clinically indicated cardiac&#xD;
             catheterization with or without angioplasty&#xD;
&#xD;
          -  Patient may have suffered myocardial infarction more than 3 days before MPI&#xD;
&#xD;
          -  Patient may have undergone percutaneous transluminal coronary angioplasty (PTCA) or&#xD;
             coronary stent placement more than 3 days prior to MPI&#xD;
&#xD;
          -  Interval between T99m-MPI and cardiac catheterization is within 30 days&#xD;
&#xD;
          -  Females are not pregnant and lactating&#xD;
&#xD;
          -  Provide signed Informed Consent prior to undergoing the study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 18 years of age&#xD;
&#xD;
          -  Female patient is pregnant or nursing&#xD;
&#xD;
          -  Patient has been involved in any other investigative, radioactive research procedure&#xD;
             within 7 days and during the study participation period&#xD;
&#xD;
          -  History of 2nd or 3rd degree AV-block, or sinus node dysfunction unless the patients&#xD;
             have a functioning artificial pacemaker&#xD;
&#xD;
          -  Myocardial infarction within 3 days before MPI&#xD;
&#xD;
          -  Percutaneous transluminal coronary angioplasty (PTCA) or stent placement within 3 days&#xD;
             prior to MPI&#xD;
&#xD;
          -  Current ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial&#xD;
             flutter&#xD;
&#xD;
          -  Current history of exacerbated COPD or asthma&#xD;
&#xD;
          -  Known hypersensitivity or contraindication to regadenoson or aminophylline&#xD;
&#xD;
          -  Use of caffeinated substance, dipyridamole-containing medication, aminophylline, or&#xD;
             xanthines containing medication (e.g. theophylline) within the 12 hours prior to&#xD;
             Lexiscan administration.&#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>Nghi Nguyen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Louis University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>March 4, 2014</last_update_submitted>
  <last_update_submitted_qc>March 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</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/NCT01700972
org study id: REGA-12B03
nct id: NCT01700972
lead sponsor: 
collaborator: 
has dmc: Yes
The current protocol for myocardial perfusion imaging (MPI) entails imaging within 30-45
      minutes after radiotracer injection, for both rest and stress studies. We hypothesize that
      early imaging 10 minutes after radiotracer injection provides high image quality and
      diagnostic accuracy comparable to 30-45 minutes MPI.
The current MPI protocol entails imaging within 30-45 minutes after radiotracer injection
      (W30 imaging), for both the rest and stress part. This delay between the radiotracer
      injection and imaging is intended to limit the nonspecific liver and gut radioactivity to the
      heart and allows an optimal imaging of the heart. A recent publication however indicates that
      an early imaging within 10 minutes after radiotracer injection (W10 imaging) appears feasible
      and may be as good as W30 imaging.

      Encouraged by the recent data, we think that a waiting time of 10 minutes is feasible while
      preserving the image quality; thus, we would like to assess the feasibility and accuracy of
      W10 imaging compared with W30 imaging in this study. The main purpose of this study is to
      obtain imaging information on the use of early imaging (W10). The feasibility of W10 imaging
      will be assessed visually using a 3-point scale as well as semiquantitatively using
      region-of-interest measurements. The accuracy of W10 imaging will be determined by comparing
      the findings of W10 with those of coronary angiography, which will be obtained within 30 days
      of the MPI and serve as reference standard. The tolerability of W10 will be assessed using
      3-point scale Questionnaires.

      This study will determine if early MPI imaging within 10 minutes works as well as imaging
      after 30-45 minutes waiting and its role in the diagnosis of coronary artery disease. The
      major advantages of this new imaging procedure include the shortening of the procedure time,
      the reduction of patient discomfort and improvement of patient care.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Feasibility and accuracy of early imaging at 10 minutes (W10) vs. standard imaging at 30-45 minute after radiotracer injection
time frame: 30 days
description: The feasibility of W10 imaging will be assessed visually using a 3-point scale as well as semiquantitatively using region-of-interest measurements. The accuracy of W10 imaging will be determined by comparing the findings of W10 with those of coronary angiography, which will be obtained within 30 days of the MPI and serve as reference standard.
measure: Tolerability of early imaging at 10 minutes (W10)
time frame: Two hours
description: The tolerability of W10 will be assessed using 3-point scale Questionnaires.
arm group label: Imaging at 10-minute vs. 30-45-minutes
arm group type: Experimental
description: The radionuclide Myoview will be administered once for the rest and stress myocardial perfusion imaging. The subsequent rest and stress imaging will be performed twice each - at 10 minutes and 30-45 minutes after radiotracer injection.
intervention type: Procedure
intervention name: Myocardial perfusion imaging
description: The radionuclide Myoview will be administered once for the rest and stress myocardial perfusion imaging. The subsequent rest and stress imaging will be performed twice each - at 10 minutes and 30-45 minutes after radiotracer injection.
arm group label: Imaging at 10-minute vs. 30-45-minutes
other name: Myocardial perfusion SPECT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nghi Nguyen, MD, PhD
role: Principal Investigator
affiliation: St. Louis University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease