<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/NCT03265535</url>
  </required_header>
  <id_info>
    <org_study_id>2016P002531</org_study_id>
    <nct_id>NCT03265535</nct_id>
  </id_info>
  <brief_title>Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging</brief_title>
  <official_title>Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      We propose a single-scan two-injection myocardial perfusion imaging protocol using ammonia.&#xD;
      Subjects will undergo single-scan two-injection imaging as well as regular stress single-scan&#xD;
      single-injection protocol and the myocardial blood flow of both techniques will be compared.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Stress MBF</measure>
    <time_frame>Single session (&lt;2 hours)</time_frame>
    <description>Difference in stress myocardial blood flow measured by the single-scan two-injection protocol versus conventional single-scan single-injection stress protocol</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Myocardial Ischemia</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <description>Subjects without history of coronary artery disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects with coronary artery disease</arm_group_label>
    <description>Subjects with coronary artery disease and abnormal SPECT myocardial perfusion imaging within the last 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Single-Scan Two-Injection Protocol</intervention_name>
    <description>Single-Scan Two-Injection Protocol</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Subjects with coronary artery disease</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of the Massachusetts General Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Healthy Volunteers:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be ≥30 and ≤75 years of age;&#xD;
&#xD;
          -  Subjects must provide informed consent prior to study procedures;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of CAD, including:&#xD;
&#xD;
          -  Prior abnormal myocardial perfusion study&#xD;
&#xD;
          -  History of MI&#xD;
&#xD;
          -  History of angina&#xD;
&#xD;
          -  Coronary artery obstruction &gt;50% on CTA and/or angiography&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt;50%&#xD;
&#xD;
          -  Any relative or absolute contraindication to adenosine stress, including:&#xD;
&#xD;
          -  2nd or 3rd degree heart block&#xD;
&#xD;
          -  Bradycardia (HR&lt;50 bpm)&#xD;
&#xD;
          -  Recent acute coronary syndrome (ACS)&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Severe heart failure (left ventricular ejection fraction &lt;15%)&#xD;
&#xD;
          -  Ventricular arrhythmia&#xD;
&#xD;
          -  Severe asthma and/or chronic obstructive pulmonary disease (COPD)&#xD;
&#xD;
          -  Baseline hypotension defined as systolic blood pressure &lt; 90 mmHg&#xD;
&#xD;
          -  Caffeine intake within 24 hours prior to imaging&#xD;
&#xD;
          -  Current use of theophylline, dipyridamole, or carbamazepine&#xD;
&#xD;
          -  Allergy or intolerance to adenosine&#xD;
&#xD;
          -  Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy&#xD;
             cannot be ruled out prior to dosing;&#xD;
&#xD;
        Subjects with CAD:&#xD;
&#xD;
        Inclusion criteria&#xD;
&#xD;
          -  Subjects must be ≥30 and ≤75 years of age;&#xD;
&#xD;
          -  Subjects must provide informed consent prior to study procedures;&#xD;
&#xD;
          -  Abnormal myocardial perfusion study within the past 12 months&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Revascularization (percutaneous coronary intervention and/or coronary artery bypass)&#xD;
             following last myocardial perfusion study&#xD;
&#xD;
          -  Acute coronary syndrome within 30 days&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt;50%&#xD;
&#xD;
          -  Any relative or absolute contraindication to adenosine stress, including:&#xD;
&#xD;
          -  2nd or 3rd degree heart block&#xD;
&#xD;
          -  Bradycardia (HR&lt;50 bpm)&#xD;
&#xD;
          -  Recent acute coronary syndrome (ACS)&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Severe heart failure (left ventricular ejection fraction &lt;15%)&#xD;
&#xD;
          -  Ventricular arrhythmia&#xD;
&#xD;
          -  Severe asthma and/or chronic obstructive pulmonary disease (COPD)&#xD;
&#xD;
          -  Baseline hypotension defined as systolic blood pressure &lt; 90 mmHg&#xD;
&#xD;
          -  Caffeine intake within 24 hours prior to imaging&#xD;
&#xD;
          -  Current use of theophylline, dipyridamole, or carbamazepine&#xD;
&#xD;
          -  Allergy or intolerance to adenosine&#xD;
&#xD;
          -  Any clinically significant acute or unstable physical or psychological disease, judged&#xD;
             by the investigators, to be incompatible with the study;&#xD;
&#xD;
          -  Radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the&#xD;
             prior 12 months);&#xD;
&#xD;
          -  Female participants only: Positive serum and/or urine pregnancy test, or lactating, or&#xD;
             possibility of pregnancy cannot be ruled out prior to dosing;&#xD;
&#xD;
          -  Inability to provide written informed consent;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Marina Macdonald-Soccorso, BS</last_name>
    <phone>617-643-1967</phone>
    <email>MMACDONALD-SOCCORSO@mgh.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marina Macdonald-Soccorso, BS</last_name>
      <phone>617-643-1967</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Georges El Fakhri</investigator_full_name>
    <investigator_title>Director, Gordon Center for Medical Imaging</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <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/NCT03265535
org study id: 2016P002531
nct id: NCT03265535
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: No
We propose a single-scan two-injection myocardial perfusion imaging protocol using ammonia.
      Subjects will undergo single-scan two-injection imaging as well as regular stress single-scan
      single-injection protocol and the myocardial blood flow of both techniques will be compared.
observational model: Other
time perspective: Prospective
measure: Stress MBF
time frame: Single session (<2 hours)
description: Difference in stress myocardial blood flow measured by the single-scan two-injection protocol versus conventional single-scan single-injection stress protocol
arm group label: Healthy Volunteers
description: Subjects without history of coronary artery disease
arm group label: Subjects with coronary artery disease
description: Subjects with coronary artery disease and abnormal SPECT myocardial perfusion imaging within the last 12 months
intervention type: Diagnostic Test
intervention name: Single-Scan Two-Injection Protocol
description: Single-Scan Two-Injection Protocol
arm group label: Healthy Volunteers
arm group label: Subjects with coronary artery disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marina Macdonald-Soccorso, BS
phone: 617-643-1967
email: MMACDONALD-SOCCORSO@mgh.harvard.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Georges El Fakhri
investigator title: Director, Gordon Center for Medical Imaging
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Ischemia
sharing ipd: No