<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/NCT03821766</url>
  </required_header>
  <id_info>
    <org_study_id>P2018/479</org_study_id>
    <nct_id>NCT03821766</nct_id>
  </id_info>
  <brief_title>Haemodynamic Abnormalities Recorded With Cardiac Catheterization Along With Body's Surface Micro-accelerometers (KT-KCG)</brief_title>
  <acronym>KT-KCG</acronym>
  <official_title>Do Abnormal Hemodynamic Features Generate Relevant Reactions and Vibrations at the Skin Level When Recorded by Micro Accelerometers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasme University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erasme University Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      The ballistocardiography (BCG) and the seismocardiography (SCG) are old techniques recording&#xD;
      the vibrations at the skin level generated by the acceleration and displacement of the blood&#xD;
      and cardiac mass at each cardiac contraction. The former records the acceleration near the&#xD;
      subject's center of mass, the latter at the local chest wall. So far, the unclear&#xD;
      physiological origin of those acceleration signals has led to important ambiguities in their&#xD;
      scientific and clinical interpretation. Therefore, several ongoing studies would aim to&#xD;
      highlight the physiological genesis of those acceleration-induced signals.&#xD;
&#xD;
      Indeed, the main objective of this study is to correlate the BCG and SCG signals recorded at&#xD;
      the body surface with several haemodynamic parameters recorded invasively during a cardiac&#xD;
      catheterisation, pulmonary pressure, wedge pressure, cardiac output to cite a few.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients suffering from severe heart failure regardless of the etiology will undergo a&#xD;
      cardiac catheterization as required by their medical condition.&#xD;
&#xD;
      The SCG and BCG signals will be recorded simultaneously to the catheterization by the mean of&#xD;
      an unintrusive and friendly device consisting of two houses, the first one placed on sternum&#xD;
      and the second one in the lumbar column. The device will record a continuous tracing&#xD;
      synchronized with the intracavitary pressure profiles recorded during the invasive procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Technical failure&#xD;
  </why_stopped>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</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>Micro-accelerations recorded at the body's surface</measure>
    <time_frame>6 months</time_frame>
    <description>Analysis of heart-induced velocities (m/s) by the means of micro-accelerometers and secondary computation of the kinetic energy (KE= 1/2 mv²) recorded with the seismocardiography and ballistocardiography at the skin level during cardiac catheterization.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Heart Failure</condition>
  <condition>Pulmonary Hypertension</condition>
  <arm_group>
    <arm_group_label>Heart failure</arm_group_label>
    <description>Patients suffering from heart failure regardless to the etiology will undergo cardiac catheterization according to their medical condition. the SCG and BCG signals will be recorded along with the intracavitary pressure profiles detected invasively with the cardiac catheterization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ballistocardiography and seismocardiography</intervention_name>
    <description>SCG and BCG signals will be recorded by the mean of an unobtrusive and friendly device consisting of two houses, the first one placed on the sternum and the second one place on the lumbar region near the subject's center of mass. The signal will be transferred to a tablet by Bluetooth and tracings will be analysed automatically with Matlab. The SCG+BCG signals are synchronized to the intracardiac pressure tracings in order to allow a comparative interpretation between the two tracings.</description>
    <arm_group_label>Heart failure</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from heart failure and undergoing a planned cardiac catheterization as&#xD;
        required by their medical condition will be asked to participate to the study.&#xD;
&#xD;
        The inclusion criteria include heart failure regardless of its etiology. Patients with a&#xD;
        left ventricle assistance device will not be enrolled because the high-frequency&#xD;
        accelerations generated by the mechanical device and transmitted to the skin level will&#xD;
        likely hamper the ballisto- and seismocardiographic signal.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 y.o. to 80 y.o.&#xD;
&#xD;
          -  Heart failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Left ventricle assistance device&#xD;
&#xD;
          -  Refused participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>August 21, 2020</last_update_submitted>
  <last_update_submitted_qc>August 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intracavitary pressure</keyword>
  <keyword>Ballistocardiography</keyword>
  <keyword>Seismocardiography</keyword>
  <keyword>Microaccelerations</keyword>
  <keyword>Kinetic energy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03821766/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03821766
org study id: P2018/479
nct id: NCT03821766
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The ballistocardiography (BCG) and the seismocardiography (SCG) are old techniques recording
      the vibrations at the skin level generated by the acceleration and displacement of the blood
      and cardiac mass at each cardiac contraction. The former records the acceleration near the
      subject's center of mass, the latter at the local chest wall. So far, the unclear
      physiological origin of those acceleration signals has led to important ambiguities in their
      scientific and clinical interpretation. Therefore, several ongoing studies would aim to
      highlight the physiological genesis of those acceleration-induced signals.

      Indeed, the main objective of this study is to correlate the BCG and SCG signals recorded at
      the body surface with several haemodynamic parameters recorded invasively during a cardiac
      catheterisation, pulmonary pressure, wedge pressure, cardiac output to cite a few.
Patients suffering from severe heart failure regardless of the etiology will undergo a
      cardiac catheterization as required by their medical condition.

      The SCG and BCG signals will be recorded simultaneously to the catheterization by the mean of
      an unintrusive and friendly device consisting of two houses, the first one placed on sternum
      and the second one in the lumbar column. The device will record a continuous tracing
      synchronized with the intracavitary pressure profiles recorded during the invasive procedure.
observational model: Cohort
time perspective: Prospective
measure: Micro-accelerations recorded at the body's surface
time frame: 6 months
description: Analysis of heart-induced velocities (m/s) by the means of micro-accelerometers and secondary computation of the kinetic energy (KE= 1/2 mv²) recorded with the seismocardiography and ballistocardiography at the skin level during cardiac catheterization.
arm group label: Heart failure
description: Patients suffering from heart failure regardless to the etiology will undergo cardiac catheterization according to their medical condition. the SCG and BCG signals will be recorded along with the intracavitary pressure profiles detected invasively with the cardiac catheterization.
intervention type: Device
intervention name: Ballistocardiography and seismocardiography
description: SCG and BCG signals will be recorded by the mean of an unobtrusive and friendly device consisting of two houses, the first one placed on the sternum and the second one place on the lumbar region near the subject's center of mass. The signal will be transferred to a tablet by Bluetooth and tracings will be analysed automatically with Matlab. The SCG+BCG signals are synchronized to the intracardiac pressure tracings in order to allow a comparative interpretation between the two tracings.
arm group label: Heart failure
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
sharing ipd: Undecided
provided document: 