<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/NCT04440072</url>
  </required_header>
  <id_info>
    <org_study_id>20-037</org_study_id>
    <nct_id>NCT04440072</nct_id>
  </id_info>
  <brief_title>Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index</brief_title>
  <acronym>ABIPULSE</acronym>
  <official_title>Comparison of 3 Ultrasonic Techniques for Measuring the Systolic Pressure Index</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Caen</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>
      Continuous Doppler ankle brachial index (ABI) is the gold standard for screening and&#xD;
      monitoring of peripheral arterial disease (PAD) but is no longer carried out in clinical&#xD;
      practice.&#xD;
&#xD;
      The recommended measurement was gradually replaced by colour or pulsed Doppler without&#xD;
      validation of these techniques.&#xD;
&#xD;
      The objective of our study is to compare these two techniques (color Doppler and pulsed&#xD;
      Doppler in echodoppler) with respect to the gold standard (continuous Doppler) for ABI&#xD;
      measurement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 17, 2020</start_date>
  <completion_date type="Anticipated">June 22, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 22, 2021</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Concordance on the IPS value measured with pulsed Doppler compared to gold standard</measure>
    <time_frame>30 minutes</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Atherosclerosis Obliterans</condition>
  <condition>Atherosclerosis Right Leg</condition>
  <condition>Atherosclerosis Left Leg</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient referred to the Vascular Medicine Department for a vascular examination with ABI&#xD;
        measurement. In most cases, these patients present with symptoms suggestive of PAD, most&#xD;
        often with vascular risk factors for atherosclerosis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient referred to the Vascular Medicine Department of Caen University Hospital for a&#xD;
        vascular examination with ABI measurement having been informed and not objecting to&#xD;
        participation in the study and benefiting from a social protection system.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with arrhythmia&#xD;
&#xD;
          -  Patient with trans-tibial or more proximal amputation&#xD;
&#xD;
          -  Patient with extensive trophic disorder not allowing measurement&#xD;
&#xD;
          -  Patient with subgonal bypass&#xD;
&#xD;
          -  Known bilateral sub-clavian stenoses&#xD;
&#xD;
          -  Patient deprived of liberty or under a measure of legal protection&#xD;
&#xD;
          -  Interned patient for the treatment of a psychiatric or physical illness&#xD;
&#xD;
          -  Patients who are legally incompetent, under the protection of justice, under&#xD;
             guardianship or trusteeship.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Direction de la recherche et de l'enseignement</last_name>
    <phone>2 31 06 57 81</phone>
    <phone_ext>+33</phone_ext>
    <email>drci-secretariat@chu-caen.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Caen</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Damien LANNEELE</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ankle brachial index</keyword>
  <keyword>color duplex ultrasound</keyword>
  <keyword>pulsed doppler</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04440072
org study id: 20-037
nct id: NCT04440072
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Continuous Doppler ankle brachial index (ABI) is the gold standard for screening and
      monitoring of peripheral arterial disease (PAD) but is no longer carried out in clinical
      practice.

      The recommended measurement was gradually replaced by colour or pulsed Doppler without
      validation of these techniques.

      The objective of our study is to compare these two techniques (color Doppler and pulsed
      Doppler in echodoppler) with respect to the gold standard (continuous Doppler) for ABI
      measurement.
observational model: Cohort
time perspective: Cross-Sectional
measure: Concordance on the IPS value measured with pulsed Doppler compared to gold standard
time frame: 30 minutes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Direction de la recherche et de l'enseignement
phone: 2 31 06 57 81
phone ext: +33
email: drci-secretariat@chu-caen.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Atherosclerosis
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
sharing ipd: Undecided