<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/NCT03802760</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01066</org_study_id>
    <nct_id>NCT03802760</nct_id>
  </id_info>
  <brief_title>Cerebral Microembolism in Cardiology</brief_title>
  <acronym>ZEMEK</acronym>
  <official_title>Cerebral Microembolism in Interventional Cardiology Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</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>
      During different interventional cardiology procedures we aim to identify cerebral microemboli&#xD;
      load. Further we aim to differentiate the quality and the quantity of cerebral microemboli.We&#xD;
      will measure cerebral microemboli in different interventional phases, e.g. during valve&#xD;
      deployment, rapid pacing, post-implantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2018</start_date>
  <completion_date type="Actual">November 6, 2022</completion_date>
  <primary_completion_date type="Actual">February 24, 2022</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>Quality of cerebral microemboli (solid vs. gaseous)</measure>
    <time_frame>intraoperative phase, expected to be approx. 4 hours</time_frame>
    <description>The quality of cerebral microemboli is measured by Doppler ultrasonography which automatically detects and analyses the Doppler signal coming from the middle cerebral artery. According to the strength of signal reflection, the signal will be qualified as solid or gaseous.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantity of cerebral microemboli load</measure>
    <time_frame>intraoperative phase, expected to be approx. 4 hours</time_frame>
    <description>The quantity of cerebral microemboli is measured by Doppler ultrasonography which automatically register the counts of solid and gaseous emboli.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral hemispheric differences (left vs. right)</measure>
    <time_frame>intraoperative phase, expected to be approx. 4 hours</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Cerebral Embolism</condition>
  <arm_group>
    <arm_group_label>TAVI patients</arm_group_label>
    <description>Patients undergoing transfemoral TAVI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MitraClip patients</arm_group_label>
    <description>Patients undergoing MitraClip implantation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TricuspidalClip</arm_group_label>
    <description>Patients undergoing TricuspidalClip implantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Doppler (TCD) ultrasound measurement</intervention_name>
    <description>Non-invasive measurement of cerebral embolic load and blood flow using TCD</description>
    <arm_group_label>MitraClip patients</arm_group_label>
    <arm_group_label>TAVI patients</arm_group_label>
    <arm_group_label>TricuspidalClip</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Interventional cardiology procedure (TAVI, MitraClip, TricuspidalClip)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to ultrasound gel or materials contained in the TCD probe&#xD;
&#xD;
          -  Missing temporal bone window&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>October 22, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Insel Gruppe AG, University Hospital Bern</investigator_affiliation>
    <investigator_full_name>Gabor Erdös</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Embolism</mesh_term>
    <mesh_term>Embolism</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/NCT03802760
org study id: 2018-01066
nct id: NCT03802760
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
During different interventional cardiology procedures we aim to identify cerebral microemboli
      load. Further we aim to differentiate the quality and the quantity of cerebral microemboli.We
      will measure cerebral microemboli in different interventional phases, e.g. during valve
      deployment, rapid pacing, post-implantation.
observational model: Cohort
time perspective: Prospective
measure: Quality of cerebral microemboli (solid vs. gaseous)
time frame: intraoperative phase, expected to be approx. 4 hours
description: The quality of cerebral microemboli is measured by Doppler ultrasonography which automatically detects and analyses the Doppler signal coming from the middle cerebral artery. According to the strength of signal reflection, the signal will be qualified as solid or gaseous.
measure: Quantity of cerebral microemboli load
time frame: intraoperative phase, expected to be approx. 4 hours
description: The quantity of cerebral microemboli is measured by Doppler ultrasonography which automatically register the counts of solid and gaseous emboli.
measure: Cerebral hemispheric differences (left vs. right)
time frame: intraoperative phase, expected to be approx. 4 hours
arm group label: TAVI patients
description: Patients undergoing transfemoral TAVI
arm group label: MitraClip patients
description: Patients undergoing MitraClip implantation
arm group label: TricuspidalClip
description: Patients undergoing TricuspidalClip implantation
intervention type: Device
intervention name: Transcranial Doppler (TCD) ultrasound measurement
description: Non-invasive measurement of cerebral embolic load and blood flow using TCD
arm group label: MitraClip patients
arm group label: TAVI patients
arm group label: TricuspidalClip
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Insel Gruppe AG, University Hospital Bern
investigator full name: Gabor Erdös
investigator title: Principal Investigator
mesh term: Intracranial Embolism
mesh term: Embolism
sharing ipd: No