<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/NCT03793049</url>
  </required_header>
  <id_info>
    <org_study_id>1030-002-03</org_study_id>
    <nct_id>NCT03793049</nct_id>
  </id_info>
  <brief_title>Repeatability and Reproducibility of the CADence™System</brief_title>
  <acronym>SEQUEL</acronym>
  <official_title>Repeatability and Reproducibility of the CADence™System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AUM Cardiovascular, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AUM Cardiovascular, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed as a prospective study to capture data for evaluating the&#xD;
      repeatability and reproducibility of the CADence™ System. The study will be conducted at 3&#xD;
      different study sites using 6 CADence™ systems. Each subject will be tested 4 separate times&#xD;
      by 2 different operators at each site and will be tested at all 3 site locations in order to&#xD;
      accomplish this evaluation. The study will enroll a total of at least 24 CADence positive&#xD;
      patients and at least 24 CADence negative patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The CADence™ system is comprised of a digital stethoscope used to record cardiac (heart)&#xD;
      sounds, with integrated sensor used to record electrical activity of the heart (ECG), a&#xD;
      single-use patient booklet, and the CADence™ Software application. CADence™ Software is a&#xD;
      clinical decision support tool for the noninvasive functional evaluation of patients&#xD;
      presenting with chest pain and at least two coronary artery disease risk factors that is&#xD;
      intended to aid a qualified clinician's analysis of normal/physiological and pathological&#xD;
      heart murmurs and in ruling out significant coronary disease as a cause for these symptoms of&#xD;
      cardiovascular disease, utilizing simultaneous recording of cardiac sounds and ECG.&#xD;
&#xD;
      The purpose of this study is to assess the precision of the CADence site using multiple&#xD;
      operators, cadence systems and clinical sites.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Actual">June 26, 2019</completion_date>
  <primary_completion_date type="Actual">June 26, 2019</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>Positive Percent Agreement and Negative Percent Agreement</measure>
    <time_frame>14 days</time_frame>
    <description>repeatability and reproducibility</description>
  </primary_outcome>
  <enrollment type="Actual">79</enrollment>
  <condition>Coronary Artery Disease</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CADence testing will be performed</intervention_name>
    <description>CADence is a noninvasive, handheld device comprised of acoustic and ECG technology and software</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with chest pain and 2 or more coronary artery disease risk factors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects clinically indicated for nuclear stress test and who satisfy all the inclusion and&#xD;
        exclusion criteria are eligible for participation.&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          1. Age 22 years or older&#xD;
&#xD;
          2. Willing and able to give informed consent&#xD;
&#xD;
          3. Clinical indication for nuclear stress test evaluation&#xD;
&#xD;
          4. Chest pain syndrome&#xD;
&#xD;
          5. Two or more coronary artery disease risk factors as defined by:&#xD;
&#xD;
               -  Dyslipidemia: LDL &gt;130 mm/dL or HDL &lt;35 mm/dL or on treatment for dyslipidemia&#xD;
&#xD;
               -  Hypertension: blood pressure &gt;140 mmHg systolic, &gt;90 mmHg diastolic or on blood&#xD;
                  pressure altering treatment&#xD;
&#xD;
               -  Obesity: BMI&gt;28&#xD;
&#xD;
               -  Current cigarette smoking&#xD;
&#xD;
               -  Diabetes: Type 1 or 2&#xD;
&#xD;
               -  Family history: coronary disease in a first or second degree relative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects clinically indicated for nuclear stress test and who satisfy all the&#xD;
             inclusion and exclusion criteria are eligible for participation.&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          1. Age 22 years or older&#xD;
&#xD;
          2. Willing and able to give informed consent&#xD;
&#xD;
          3. Clinical indication for nuclear stress test evaluation&#xD;
&#xD;
          4. Chest pain syndrome&#xD;
&#xD;
          5. Two or more coronary artery disease risk factors as defined by:&#xD;
&#xD;
               -  Dyslipidemia: LDL &gt;130 mm/dL or HDL &lt;35 mm/dL or on treatment for dyslipidemia&#xD;
&#xD;
               -  Hypertension: blood pressure &gt;140 mmHg systolic, &gt;90 mmHg diastolic or on blood&#xD;
                  pressure altering treatment&#xD;
&#xD;
               -  Obesity: BMI&gt;28&#xD;
&#xD;
               -  Current cigarette smoking&#xD;
&#xD;
               -  Diabetes: Type 1 or 2&#xD;
&#xD;
               -  Family history: coronary disease in a first or second degree relative&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Body Mass Index (BMI)&lt;18.5 or BMI &gt;40&#xD;
&#xD;
          2. Known coronary disease as defined as:&#xD;
&#xD;
               -  Prior bypass surgery or coronary stenting&#xD;
&#xD;
               -  Q-wave infarction on a past EKG (&gt;0.01 sec Q-wave duration in two adjacent leads)&#xD;
&#xD;
          3. Presence of pacemaker/defibrillator&#xD;
&#xD;
          4. Presence of artificial valve&#xD;
&#xD;
          5. Presence of obvious cyanotic or pre-diagnosed congenital heart defect and coarctation&#xD;
             of the aorta&#xD;
&#xD;
          6. The presence of murmurs including moderate to severe valve disease, ventricular septal&#xD;
             defects, and AV fistulae&#xD;
&#xD;
          7. Presence of moderate or severe valve disease as defined by &gt;1/6 heart murmur on&#xD;
             physical diagnosis&#xD;
&#xD;
          8. Left Ventricular Assist Device (LVAD)&#xD;
&#xD;
          9. Presence of scars on the site thorax areas&#xD;
&#xD;
         10. Participation in trial within 30 days prior to collecting CADenceTM data except&#xD;
             participation in registry studies&#xD;
&#xD;
         11. Asthma with wheezing&#xD;
&#xD;
         12. Inability to lie flat in the supine position&#xD;
&#xD;
         13. Acute coronary syndrome with elevated cardiac biomarkers (TP&gt;3x upper limit of normal&#xD;
             (ULN) or CKMB&gt;3x ULN)&#xD;
&#xD;
         14. Heart transplant&#xD;
&#xD;
         15. Current cocaine use (within the past 24 hours, as reported by subject)&#xD;
&#xD;
         16. Chronic Obstructive Pulmonary Disease (COPD)&#xD;
&#xD;
         17. Patient is not an acceptable candidate for CT angiography:&#xD;
&#xD;
               -  Renal failure with GFR &lt;50&#xD;
&#xD;
               -  Iodinated contrast allergy&#xD;
&#xD;
               -  Elevated heart rate which cannot be controlled sufficiently to achieve a good CT&#xD;
                  angiogram&#xD;
&#xD;
               -  Body weight &gt;350lbs&#xD;
&#xD;
               -  Persistent sinus rhythm abnormalities (e.g., atrial fibrillation) based on&#xD;
                  medical history.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ROBERT WILSON, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>910 Medical</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northfield Urgent Care Clinic</name>
      <address>
        <city>Northfield</city>
        <state>Minnesota</state>
        <zip>55057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pivot Point Medical</name>
      <address>
        <city>Northfield</city>
        <state>Minnesota</state>
        <zip>55057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Neglia D, Rovai D, Caselli C, Pietila M, Teresinska A, Aguade-Bruix S, Pizzi MN, Todiere G, Gimelli A, Schroeder S, Drosch T, Poddighe R, Casolo G, Anagnostopoulos C, Pugliese F, Rouzet F, Le Guludec D, Cappelli F, Valente S, Gensini GF, Zawaideh C, Capitanio S, Sambuceti G, Marsico F, Perrone Filardi P, Fernandez-Golfin C, Rincon LM, Graner FP, de Graaf MA, Fiechter M, Stehli J, Gaemperli O, Reyes E, Nkomo S, Maki M, Lorenzoni V, Turchetti G, Carpeggiani C, Marinelli M, Puzzuoli S, Mangione M, Marcheschi P, Mariani F, Giannessi D, Nekolla S, Lombardi M, Sicari R, Scholte AJ, Zamorano JL, Kaufmann PA, Underwood SR, Knuuti J; EVINCI Study Investigators. Detection of significant coronary artery disease by noninvasive anatomical and functional imaging. Circ Cardiovasc Imaging. 2015 Mar;8(3):e002179. doi: 10.1161/CIRCIMAGING.114.002179.</citation>
    <PMID>25711274</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>July 8, 2019</last_update_submitted>
  <last_update_submitted_qc>July 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acoustic</keyword>
  <keyword>ECG</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>WILL NOT BE SHARED</ipd_description>
  </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/NCT03793049
org study id: 1030-002-03
nct id: NCT03793049
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This study is designed as a prospective study to capture data for evaluating the
      repeatability and reproducibility of the CADence™ System. The study will be conducted at 3
      different study sites using 6 CADence™ systems. Each subject will be tested 4 separate times
      by 2 different operators at each site and will be tested at all 3 site locations in order to
      accomplish this evaluation. The study will enroll a total of at least 24 CADence positive
      patients and at least 24 CADence negative patients.
The CADence™ system is comprised of a digital stethoscope used to record cardiac (heart)
      sounds, with integrated sensor used to record electrical activity of the heart (ECG), a
      single-use patient booklet, and the CADence™ Software application. CADence™ Software is a
      clinical decision support tool for the noninvasive functional evaluation of patients
      presenting with chest pain and at least two coronary artery disease risk factors that is
      intended to aid a qualified clinician's analysis of normal/physiological and pathological
      heart murmurs and in ruling out significant coronary disease as a cause for these symptoms of
      cardiovascular disease, utilizing simultaneous recording of cardiac sounds and ECG.

      The purpose of this study is to assess the precision of the CADence site using multiple
      operators, cadence systems and clinical sites.
observational model: Case-Control
time perspective: Prospective
measure: Positive Percent Agreement and Negative Percent Agreement
time frame: 14 days
description: repeatability and reproducibility
intervention type: Device
intervention name: CADence testing will be performed
description: CADence is a noninvasive, handheld device comprised of acoustic and ECG technology and software
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: ROBERT WILSON, MD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
facility: 
facility: 
country: United States
citation: Neglia D, Rovai D, Caselli C, Pietila M, Teresinska A, Aguade-Bruix S, Pizzi MN, Todiere G, Gimelli A, Schroeder S, Drosch T, Poddighe R, Casolo G, Anagnostopoulos C, Pugliese F, Rouzet F, Le Guludec D, Cappelli F, Valente S, Gensini GF, Zawaideh C, Capitanio S, Sambuceti G, Marsico F, Perrone Filardi P, Fernandez-Golfin C, Rincon LM, Graner FP, de Graaf MA, Fiechter M, Stehli J, Gaemperli O, Reyes E, Nkomo S, Maki M, Lorenzoni V, Turchetti G, Carpeggiani C, Marinelli M, Puzzuoli S, Mangione M, Marcheschi P, Mariani F, Giannessi D, Nekolla S, Lombardi M, Sicari R, Scholte AJ, Zamorano JL, Kaufmann PA, Underwood SR, Knuuti J; EVINCI Study Investigators. Detection of significant coronary artery disease by noninvasive anatomical and functional imaging. Circ Cardiovasc Imaging. 2015 Mar;8(3):e002179. doi: 10.1161/CIRCIMAGING.114.002179.
PMID: 25711274
responsible party type: Sponsor
mesh term: Coronary Artery Disease
sharing ipd: No
ipd description: WILL NOT BE SHARED