<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/NCT02994615</url>
  </required_header>
  <id_info>
    <org_study_id>108627</org_study_id>
    <nct_id>NCT02994615</nct_id>
  </id_info>
  <brief_title>Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy</brief_title>
  <acronym>PRIMARy</acronym>
  <official_title>Evaluating Microvascular Dysfunction in Symptomatic Patients With HypertroPhic CaRdiomyopathy: The Index of MicrovAscular Resistance (IMR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with hypertrophic cardiomyopathy are being compared to a control group. IMR will be&#xD;
      assessed with a pressure wire. Clinical f/u at 3 months and 6 months and a 48 hour holter&#xD;
      monitor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">June 2020</completion_date>
  <primary_completion_date type="Actual">June 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>IMR in patients with hypertrophic cardiomyopathy (HCM) versus controls</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of ventricular tachycardia</measure>
    <time_frame>6 months</time_frame>
    <description>Measured during 48 h recording after 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chest pain - Canadian Cardiovascular Society (CCS) class</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shortness of breath - NYHA class</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">19</enrollment>
  <condition>Hypertrophic Cardiomyopathy</condition>
  <arm_group>
    <arm_group_label>hypertrophic cardiomyopathy</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with symptomatic hypertrophic cardiomyopathy versus controls (patients undergoing&#xD;
        coronary angiography and FFR&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-80&#xD;
&#xD;
          -  Already have an indication for coronary angiography&#xD;
&#xD;
          -  Previous diagnosis of hypertrophic cardiomyopathy (unless control)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fractional flow reserve found to be significant (FFR &lt; 0.8)&#xD;
&#xD;
          -  Already have a condition associated with or likely to be associated with an elevated&#xD;
             IMR (diabetes, cardiac syndrome X, takotsubo cardiomyopathy, hypertensive&#xD;
             cardiomyopathy, severe aortic stenosis, STEMI)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shahar Lavi</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Health Sceinces Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>September 28, 2020</last_update_submitted>
  <last_update_submitted_qc>September 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Shahar Lavi</investigator_full_name>
    <investigator_title>Director of Cardiovascular Interventional Research</investigator_title>
  </responsible_party>
  <keyword>Index of Microvascular Resistance</keyword>
  <keyword>Microvascular dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Cardiomyopathy, Hypertrophic</mesh_term>
    <mesh_term>Hypertrophy</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/NCT02994615
org study id: 108627
nct id: NCT02994615
lead sponsor: 
has dmc: No
Patients with hypertrophic cardiomyopathy are being compared to a control group. IMR will be
      assessed with a pressure wire. Clinical f/u at 3 months and 6 months and a 48 hour holter
      monitor.
observational model: Case-Control
time perspective: Prospective
measure: IMR in patients with hypertrophic cardiomyopathy (HCM) versus controls
time frame: 1 day
measure: Number of ventricular tachycardia
time frame: 6 months
description: Measured during 48 h recording after 6 months
measure: Chest pain - Canadian Cardiovascular Society (CCS) class
time frame: Up to 6 months
measure: Shortness of breath - NYHA class
time frame: Up to 6 months
arm group label: hypertrophic cardiomyopathy
arm group label: Control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Shahar Lavi
role: Principal Investigator
affiliation: London Health Sceinces Centre
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Shahar Lavi
investigator title: Director of Cardiovascular Interventional Research
mesh term: Cardiomyopathies
mesh term: Cardiomyopathy, Hypertrophic
mesh term: Hypertrophy
sharing ipd: No