<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/NCT03827512</url>
  </required_header>
  <id_info>
    <org_study_id>35RC18_30019_APP-Wave-PAD</org_study_id>
    <nct_id>NCT03827512</nct_id>
  </id_info>
  <brief_title>Arterial Doppler Waveforms Analysis in PAD</brief_title>
  <acronym>APP-Wave-PAD</acronym>
  <official_title>Assessment of Professional Practices - Arterial Doppler Waveforms Analysis in PAD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>French Society of Vascular Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rennes 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 main objective is to evaluate the differences of terminology used when describing&#xD;
      arterial doppler waveforms.&#xD;
&#xD;
      To assess the impact of an educational process&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peripheral artery disease (PAD) is a common pathology that affects more than 200 million&#xD;
      people worldwide. The prevalence of this pathology is estimated in France at 11% in patients&#xD;
      over 40 years old. The Doppler arterial waveforms analysis is an important element to assess&#xD;
      the hemodynamic state of a patient and contributes to the diagnosis of the pathology. A&#xD;
      number of classifications have been proposed but their use varies from one university to&#xD;
      another. We hypothesize that there is a great heterogeneity in the description of the&#xD;
      arterial Doppler flow analysis. In addition, a new classification (Saint-Bonnet) has recently&#xD;
      been proposed and we will evaluate the effect of the use of this one. The main objective is&#xD;
      to evaluate the differences of terminology used when describing arterial Doppler waveforms.&#xD;
&#xD;
      The secondary objectives are: to understand the variations observed and expected (initial,&#xD;
      continuous training, place of exercise ...) and to study the effect of a new classification&#xD;
      on the heterogeneity of responses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Differences of terminology</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Number of different terminologies used by the vascular physicians to describe the arterial flows</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of a new classification on the heterogeneity of terminology used</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Comparison of the number of terminology used without classification and the number of terminology used with a classification (Saint-Bonnet)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Variations of description of the arterial Doppler waveforms</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Significant difference in terms of heterogeneity by region or place of formation</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>French Vascular Physicians</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Doppler arterial waveforms analysis</intervention_name>
    <description>terminology used when describing arterial Doppler waveforms</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Vascular physicians enrolled in the mailing list of French society of vascular medicine&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Vascular physicians enrolled in the mailing list of French society of vascular&#xD;
             medicine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillaume MAHE, MD PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>July 17, 2019</last_update_submitted>
  <last_update_submitted_qc>July 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vascular physicians</keyword>
  <keyword>Peripheral artery disease</keyword>
  <keyword>classification</keyword>
  <keyword>doppler waveforms</keyword>
  <keyword>Saint-Bonnet</keyword>
  <!-- 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/NCT03827512
org study id: 35RC18_30019_APP-Wave-PAD
nct id: NCT03827512
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective is to evaluate the differences of terminology used when describing
      arterial doppler waveforms.

      To assess the impact of an educational process
Peripheral artery disease (PAD) is a common pathology that affects more than 200 million
      people worldwide. The prevalence of this pathology is estimated in France at 11% in patients
      over 40 years old. The Doppler arterial waveforms analysis is an important element to assess
      the hemodynamic state of a patient and contributes to the diagnosis of the pathology. A
      number of classifications have been proposed but their use varies from one university to
      another. We hypothesize that there is a great heterogeneity in the description of the
      arterial Doppler flow analysis. In addition, a new classification (Saint-Bonnet) has recently
      been proposed and we will evaluate the effect of the use of this one. The main objective is
      to evaluate the differences of terminology used when describing arterial Doppler waveforms.

      The secondary objectives are: to understand the variations observed and expected (initial,
      continuous training, place of exercise ...) and to study the effect of a new classification
      on the heterogeneity of responses.
observational model: Other
time perspective: Cross-Sectional
measure: Differences of terminology
time frame: through study completion, an average of 1 year
description: Number of different terminologies used by the vascular physicians to describe the arterial flows
measure: Effect of a new classification on the heterogeneity of terminology used
time frame: through study completion, an average of 1 year
description: Comparison of the number of terminology used without classification and the number of terminology used with a classification (Saint-Bonnet)
measure: Variations of description of the arterial Doppler waveforms
time frame: through study completion, an average of 1 year
description: Significant difference in terms of heterogeneity by region or place of formation
intervention type: Other
intervention name: Doppler arterial waveforms analysis
description: terminology used when describing arterial Doppler waveforms
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Guillaume MAHE, MD PHD
role: Principal Investigator
affiliation: Rennes University Hospital
facility: 
country: France
responsible party type: Sponsor