xml: <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/NCT06008600</url>
    </required_header>
    <id_info>
      <org_study_id>P2021/414 / B4062021000223</org_study_id>
      <nct_id>NCT06008600</nct_id>
    </id_info>
    <brief_title>KINO-DYSPNEA: Validation of Kinocardiography to Distinguish Dyspnea of Cardiac Origin From Others</brief_title>
    <official_title>KINO-DYSPNEA: Validation of Kinocardiography to Distinguish Dyspnea of Cardiac Origin From Others</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Tivoli</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Tivoli</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Seismocardiography (SCG) measures the thoracic vibrations caused by the cardiac contraction&#xD;
        and ejection of blood into the great vessels. Current smartphones with gyroscopes and&#xD;
        accelerometers can measure these vibrations. Based on these components we measure and&#xD;
        quantify the cardiac kinetic energy (kinocardiography) in order to differentiate dyspnea of&#xD;
        cardiac origin from dyspnea of other origin. The study is conducted in an emergency service&#xD;
        where a smartphone performs the measurement during 3 minutes. The results of the&#xD;
        kinocardiography-based classification are then compared to the final diagnosis made by a&#xD;
        physician. Currently, 235 patients have been included in the clinical study since May 2022.&#xD;
        This rapid and non-invasive measurement allows the aid-to-diagnosis of heart failure without&#xD;
        being influenced by other factors like the renal function for example that can be NT-pro BNP&#xD;
        blood marker.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 19, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>1 Month</target_duration>
    <primary_outcome>
      <measure>Evaluate the ability of the Kinocardiography technique to discriminate cardiac caused dyspnea from others.</measure>
      <time_frame>18 months</time_frame>
      <description>Area under the receiver operating characteristic curve (AUROC), negative predictive value (NPV) and specificity, with two-sided 95% CIs.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Open retrospective exploratory study to validate the physiological interpretation of Kinocardiography in a clinical environment.</measure>
      <time_frame>18 months</time_frame>
      <description>Establish a link between cardiac kinetic energy distribution in the cardiac cycle between major active clinical syndromes that may be concomitant in the field of cardiac disorders (hypertension, atrial fibrillation, ischemia, valvulopathy, heart-failure,…) and pulmonary (asthma, infection,..). These clinical diagnoses are supported by the physical examination and the patient's medical record at inclusion, with the aid of a measurement of troponin and NTBNP</description>
    </secondary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Dyspnea</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Kinocardiography</intervention_name>
      <description>Smartphone (application with seismocardiography)</description>
      <other_name>NT-pro BNP blood measurement</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Any adult presenting with dyspnea to the emergency department or cardiology consultation.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Dyspnea.&#xD;
  &#xD;
            -  Adults aged above 18 years old.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients younger than 18 years old.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Tuan Long Tran, Doctor</last_name>
      <phone>+32 64 27 48 61</phone>
      <email>ttran@chu-tivoli.be</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU Tivoli</name>
        <address>
          <city>La Louvière</city>
          <state>Hainaut</state>
          <zip>7100</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Tuan Long Tran, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Virginie Meurant, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <reference>
      <citation>Hossein A, Rabineau J, Gorlier D, Pinki F, van de Borne P, Nonclercq A, Migeotte PF. Effects of acquisition device, sampling rate, and record length on kinocardiography during position-induced haemodynamic changes. Biomed Eng Online. 2021 Jan 6;20(1):3. doi: 10.1186/s12938-020-00837-5.</citation>
      <PMID>33407507</PMID>
    </reference>
    <reference>
      <citation>Morra S, Hossein A, Rabineau J, Gorlier D, Racape J, Migeotte PF, van de Borne P. Assessment of left ventricular twist by 3D ballistocardiography and seismocardiography compared with 2D STI echocardiography in a context of enhanced inotropism in healthy subjects. Sci Rep. 2021 Jan 12;11(1):683. doi: 10.1038/s41598-020-79933-4.</citation>
      <PMID>33436841</PMID>
    </reference>
    <reference>
      <citation>Morra S, Pitisci L, Su F, Hossein A, Rabineau J, Racape J, Gorlier D, Herpain A, Migeotte PF, Creteur J, van de Borne P. Quantification of Cardiac Kinetic Energy and Its Changes During Transmural Myocardial Infarction Assessed by Multi-Dimensional Seismocardiography. Front Cardiovasc Med. 2021 Mar 8;8:603319. doi: 10.3389/fcvm.2021.603319. eCollection 2021.</citation>
      <PMID>33763456</PMID>
    </reference>
    <reference>
      <citation>Hossein A, Rabineau J, Gorlier D, Del Rio JIJ, van de Borne P, Migeotte PF, Nonclercq A. Kinocardiography Derived from Ballistocardiography and Seismocardiography Shows High Repeatability in Healthy Subjects. Sensors (Basel). 2021 Jan 26;21(3):815. doi: 10.3390/s21030815.</citation>
      <PMID>33530417</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</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>Dyspnea</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008600
  org study id: P2021/414 / B4062021000223
  nct id: NCT06008600
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Seismocardiography (SCG) measures the thoracic vibrations caused by the cardiac contraction
        and ejection of blood into the great vessels. Current smartphones with gyroscopes and
        accelerometers can measure these vibrations. Based on these components we measure and
        quantify the cardiac kinetic energy (kinocardiography) in order to differentiate dyspnea of
        cardiac origin from dyspnea of other origin. The study is conducted in an emergency service
        where a smartphone performs the measurement during 3 minutes. The results of the
        kinocardiography-based classification are then compared to the final diagnosis made by a
        physician. Currently, 235 patients have been included in the clinical study since May 2022.
        This rapid and non-invasive measurement allows the aid-to-diagnosis of heart failure without
        being influenced by other factors like the renal function for example that can be NT-pro BNP
        blood marker.
  observational model: Other
  time perspective: Cross-Sectional
  measure: Evaluate the ability of the Kinocardiography technique to discriminate cardiac caused dyspnea from others.
  time frame: 18 months
  description: Area under the receiver operating characteristic curve (AUROC), negative predictive value (NPV) and specificity, with two-sided 95% CIs.
  measure: Open retrospective exploratory study to validate the physiological interpretation of Kinocardiography in a clinical environment.
  time frame: 18 months
  description: Establish a link between cardiac kinetic energy distribution in the cardiac cycle between major active clinical syndromes that may be concomitant in the field of cardiac disorders (hypertension, atrial fibrillation, ischemia, valvulopathy, heart-failure,…) and pulmonary (asthma, infection,..). These clinical diagnoses are supported by the physical examination and the patient's medical record at inclusion, with the aid of a measurement of troponin and NTBNP
  intervention type: Device
  intervention name: Kinocardiography
  description: Smartphone (application with seismocardiography)
  other name: NT-pro BNP blood measurement
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Tuan Long Tran, Doctor
  phone: +32 64 27 48 61
  email: ttran@chu-tivoli.be
  facility: 
  status: Recruiting
  investigator: 
  investigator: 
  country: Belgium
  citation: Hossein A, Rabineau J, Gorlier D, Pinki F, van de Borne P, Nonclercq A, Migeotte PF. Effects of acquisition device, sampling rate, and record length on kinocardiography during position-induced haemodynamic changes. Biomed Eng Online. 2021 Jan 6;20(1):3. doi: 10.1186/s12938-020-00837-5.
  PMID: 33407507
  citation: Morra S, Hossein A, Rabineau J, Gorlier D, Racape J, Migeotte PF, van de Borne P. Assessment of left ventricular twist by 3D ballistocardiography and seismocardiography compared with 2D STI echocardiography in a context of enhanced inotropism in healthy subjects. Sci Rep. 2021 Jan 12;11(1):683. doi: 10.1038/s41598-020-79933-4.
  PMID: 33436841
  citation: Morra S, Pitisci L, Su F, Hossein A, Rabineau J, Racape J, Gorlier D, Herpain A, Migeotte PF, Creteur J, van de Borne P. Quantification of Cardiac Kinetic Energy and Its Changes During Transmural Myocardial Infarction Assessed by Multi-Dimensional Seismocardiography. Front Cardiovasc Med. 2021 Mar 8;8:603319. doi: 10.3389/fcvm.2021.603319. eCollection 2021.
  PMID: 33763456
  citation: Hossein A, Rabineau J, Gorlier D, Del Rio JIJ, van de Borne P, Migeotte PF, Nonclercq A. Kinocardiography Derived from Ballistocardiography and Seismocardiography Shows High Repeatability in Healthy Subjects. Sensors (Basel). 2021 Jan 26;21(3):815. doi: 10.3390/s21030815.
  PMID: 33530417
  responsible party type: Sponsor
  mesh term: Dyspnea