<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/NCT02220569</url>
  </required_header>
  <id_info>
    <org_study_id>4073</org_study_id>
    <nct_id>NCT02220569</nct_id>
  </id_info>
  <brief_title>PhysioFlow to Detect Cardiotoxicity in Chemo</brief_title>
  <acronym>PULSE-ECCho</acronym>
  <official_title>PhysioFlow Use in Longterm Screening and Evaluation of Cardiotoxicity in Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      PULSE-ECCho will focus on trying to detect cardiotoxicity in cancer patients receiving&#xD;
      chemotherapy early on in order to avoid irreversible damage. In addition to that, we will&#xD;
      test if the PhysioFlow is non-inferior to the conventional MUGA scan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our objective is to compare the PhysioFlow to the MUGA scan and see if the results are&#xD;
      statistically the same using both techniques. This is what is known as a non-inferior study.&#xD;
      The advantage of PhysioFlow is that it is non-invasive, fast and it is done at the bedside or&#xD;
      while the patient is receiving his or her chemotherapy.&#xD;
&#xD;
      The patient will be tested with the MUGA scan, as per the standard of care, before&#xD;
      chemotherapy is initiated and at every 3 months. The patient will also be tested with the&#xD;
      PhysioFlow at the same dates of the MUGA scan. In addition to that, the patients will be&#xD;
      tested at each chemotherapy cycle with the PhysioFlow.&#xD;
&#xD;
      Should the PhysioFlow indicate the patient has a cardiac toxicity as the patient is receiving&#xD;
      chemotherapy, the results will be confirmed with the MUGA scan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">July 2016</completion_date>
  <primary_completion_date type="Anticipated">July 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>comparing the change in ejection fraction measured by physioflow and MUGA scan</measure>
    <time_frame>at initial diagnosis and after 3 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>acceptance score on the five-point Likert Scale to measure tolerability</measure>
    <time_frame>up to 24 hrs</time_frame>
    <description>At the end of physioflow and or MUGA scan, a questionnaire to assess acceptance was proposed to all patients. The following aspects were evaluated: preparation and information before the imaging examination, degree of preceding concern, comfort, helplessness during the examination, pain experienced, degree of overall satisfaction. Evaluation was performed with a five-point qualitative Likert scale: very low, low, moderate, high, very high</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Chemotherapy, Cancer, Cardiotoxicity, Physioflow</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients presenting to the oncology day clinic at Royal Victoria hospital and receiving&#xD;
        chemotherapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age above 18 years old&#xD;
&#xD;
          2. Histologically confirmed diagnosis of cancer&#xD;
&#xD;
          3. ECOG 0 to 2&#xD;
&#xD;
          4. Provide written consent after the investigational nature, study design, risks and&#xD;
             benefits of the study have been explained&#xD;
&#xD;
          5. Able to adhere to the study visit schedule and other protocol requirements&#xD;
&#xD;
        Control Group&#xD;
&#xD;
          1. Age above 18 years old&#xD;
&#xD;
          2. No previous history of cancer&#xD;
&#xD;
          3. ECOG 0 to 2&#xD;
&#xD;
          4. Did not receive chemotherapeutic agents (even if outside the context of cancer)&#xD;
&#xD;
          5. Provide written consent after the investigational nature, study design, risks and&#xD;
             benefits of the study have been explained&#xD;
&#xD;
          6. Able to adhere to the study visit schedule and other protocol requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age less than 18 years&#xD;
&#xD;
          2. ECOG 3-4&#xD;
&#xD;
          3. Suspected or proven severe aortic insufficiency&#xD;
&#xD;
          4. Patient under cardiopulmonary bypass assistance (I.e.: Left ventricular assisting&#xD;
             device)&#xD;
&#xD;
          5. Congenital cardiac deformities ,such as septal defects&#xD;
&#xD;
          6. Refuse to comply with the specified visit schedules and requirements&#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>Nathaniel Bouganim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ralph Maroun, M.D.</last_name>
    <phone>5147080701</phone>
    <email>ralph.maroun@mail.mcgill.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>McGill university health center, Royal Victoria hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>h3a 1a1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <phone>5147080701</phone>
      <email>ralph-maroun@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ralph Maroun</last_name>
    </contact_backup>
    <investigator>
      <last_name>Nathaniel Bouganim, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>h4a 1v3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ralph Maroun, MD</last_name>
      <phone>5147080701</phone>
      <email>ralph-maroun@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Nathaniel Bouganim, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>September 21, 2015</last_update_submitted>
  <last_update_submitted_qc>September 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Nathaniel Bouganim</investigator_full_name>
    <investigator_title>Dr. Nathaniel Bouganim, Medical Oncologist at Royal Victoria Hospital muhc</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiotoxicity</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/NCT02220569
org study id: 4073
nct id: NCT02220569
lead sponsor: 
has dmc: Yes
PULSE-ECCho will focus on trying to detect cardiotoxicity in cancer patients receiving
      chemotherapy early on in order to avoid irreversible damage. In addition to that, we will
      test if the PhysioFlow is non-inferior to the conventional MUGA scan.
Our objective is to compare the PhysioFlow to the MUGA scan and see if the results are
      statistically the same using both techniques. This is what is known as a non-inferior study.
      The advantage of PhysioFlow is that it is non-invasive, fast and it is done at the bedside or
      while the patient is receiving his or her chemotherapy.

      The patient will be tested with the MUGA scan, as per the standard of care, before
      chemotherapy is initiated and at every 3 months. The patient will also be tested with the
      PhysioFlow at the same dates of the MUGA scan. In addition to that, the patients will be
      tested at each chemotherapy cycle with the PhysioFlow.

      Should the PhysioFlow indicate the patient has a cardiac toxicity as the patient is receiving
      chemotherapy, the results will be confirmed with the MUGA scan.
observational model: Cohort
time perspective: Prospective
measure: comparing the change in ejection fraction measured by physioflow and MUGA scan
time frame: at initial diagnosis and after 3 month
measure: acceptance score on the five-point Likert Scale to measure tolerability
time frame: up to 24 hrs
description: At the end of physioflow and or MUGA scan, a questionnaire to assess acceptance was proposed to all patients. The following aspects were evaluated: preparation and information before the imaging examination, degree of preceding concern, comfort, helplessness during the examination, pain experienced, degree of overall satisfaction. Evaluation was performed with a five-point qualitative Likert scale: very low, low, moderate, high, very high
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nathaniel Bouganim, MD
role: Principal Investigator
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
last name: Ralph Maroun, M.D.
phone: 5147080701
email: ralph.maroun@mail.mcgill.ca
facility: 
status: Not yet recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Nathaniel Bouganim
investigator title: Dr. Nathaniel Bouganim, Medical Oncologist at Royal Victoria Hospital muhc
mesh term: Cardiotoxicity