<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/NCT02997436</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01157-44</org_study_id>
    <nct_id>NCT02997436</nct_id>
  </id_info>
  <brief_title>First Approach for Aspirin Misuse Objective Screening</brief_title>
  <acronym>FirstAMOS</acronym>
  <official_title>Asa Test ; un Nouvel Outil Dans le dépistage du Traitement Par Aspirine ? (This Official Titre is in French and Contains no Spelling Error. English Translation for it Would be : &quot;ASA-test. A New Tool for the Screening of Aspirin Treatment&quot;)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      prospective interventional study. The aim is to analyse the effect of usual ongoing&#xD;
      treatments over the microvascular cutaneous response to galvanic current application (Current&#xD;
      induced vasodilation ; CIV) on the forearm of subjects referred for ultrasound investigations&#xD;
      due to suspicion of peripheral artery disease. Hypothesis is that the use of aspirin (even at&#xD;
      low dose) abolishes the response .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At admission eligible patients are proposed to participate. Written consent is signed after&#xD;
      complete oral and written explanation of the protocol is signed.&#xD;
&#xD;
      No register of non-included patients will be kept. In included patients, in parallel to the&#xD;
      routine ultrasound investigation for which the patient is referred, microvascular&#xD;
      investigation will be performed as explained later in arm description.&#xD;
&#xD;
      Usual ongoing treatments are obtained by history and recorded. The end of the visit is the&#xD;
      end of the participation of the subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 4, 2017</start_date>
  <completion_date type="Actual">April 10, 2017</completion_date>
  <primary_completion_date type="Actual">April 10, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>correlation of treatments to CIV response.</measure>
    <time_frame>10 minutes after the second period of current application</time_frame>
    <description>Classification of drugs in drug type categories. encoding in 1 (presence) or 0 ug (absence) of the drug category in the usual treatment of the patient. Multiple regression analysis of the different drug categories as factors influencing the increase in skin blood flow after CIV.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <arm_group>
    <arm_group_label>PAD patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients referred for vascular ultrasound investigation for suspicion of peripheral artery disease (PAD).&#xD;
Intervention is measurement of microvascular response to current application on the skin by Laser speckle flowmetry</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laser speckle flowmetry</intervention_name>
    <description>A galvanic current (0.1 mA) will be applied between 2 patches on the forearm of patient and protocol was repeated at 4 minutes.&#xD;
Microvascular response to current application (CIV) will be recorded by laser speckle flowmetry 10 minutes later.&#xD;
Measurement of the value of skin blood flow (by laser speckle) at the stimulated area as compare to a non stimulated adjacent skin value taken as a reference Usual treatment will be recorded</description>
    <arm_group_label>PAD patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects referred for investigation of peripheral arterial disease.&#xD;
&#xD;
          -  Affiliation to the French National healthcare system&#xD;
&#xD;
          -  French speaking patients&#xD;
&#xD;
          -  Ability to stand still for half a minute.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  inability to understand the study goal&#xD;
&#xD;
          -  Patients protected by decision of law&#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_official>
    <last_name>Marie-Sophie Fernandez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UH Angers</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pierre Abraham, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UH Angers</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Philippe Bouye, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UH Angers</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Valmont Richard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UH Angers</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vincent Azzola, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UH Angers</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UH Angers</name>
      <address>
        <city>Angers</city>
        <zip>49100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>October 30, 2017</last_update_submitted>
  <last_update_submitted_qc>October 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2017</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>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</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/NCT02997436
org study id: 2016-A01157-44
nct id: NCT02997436
lead sponsor: 
has dmc: Yes
prospective interventional study. The aim is to analyse the effect of usual ongoing
      treatments over the microvascular cutaneous response to galvanic current application (Current
      induced vasodilation ; CIV) on the forearm of subjects referred for ultrasound investigations
      due to suspicion of peripheral artery disease. Hypothesis is that the use of aspirin (even at
      low dose) abolishes the response .
At admission eligible patients are proposed to participate. Written consent is signed after
      complete oral and written explanation of the protocol is signed.

      No register of non-included patients will be kept. In included patients, in parallel to the
      routine ultrasound investigation for which the patient is referred, microvascular
      investigation will be performed as explained later in arm description.

      Usual ongoing treatments are obtained by history and recorded. The end of the visit is the
      end of the participation of the subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: correlation of treatments to CIV response.
time frame: 10 minutes after the second period of current application
description: Classification of drugs in drug type categories. encoding in 1 (presence) or 0 ug (absence) of the drug category in the usual treatment of the patient. Multiple regression analysis of the different drug categories as factors influencing the increase in skin blood flow after CIV.
arm group label: PAD patients
arm group type: Experimental
description: Patients referred for vascular ultrasound investigation for suspicion of peripheral artery disease (PAD).
Intervention is measurement of microvascular response to current application on the skin by Laser speckle flowmetry
intervention type: Device
intervention name: Laser speckle flowmetry
description: A galvanic current (0.1 mA) will be applied between 2 patches on the forearm of patient and protocol was repeated at 4 minutes.
Microvascular response to current application (CIV) will be recorded by laser speckle flowmetry 10 minutes later.
Measurement of the value of skin blood flow (by laser speckle) at the stimulated area as compare to a non stimulated adjacent skin value taken as a reference Usual treatment will be recorded
arm group label: PAD patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marie-Sophie Fernandez, MD
role: Principal Investigator
affiliation: UH Angers
last name: Pierre Abraham, MD, PhD
role: Principal Investigator
affiliation: UH Angers
last name: Philippe Bouye, MD
role: Principal Investigator
affiliation: UH Angers
last name: Valmont Richard, MD
role: Principal Investigator
affiliation: UH Angers
last name: Vincent Azzola, MD
role: Principal Investigator
affiliation: UH Angers
facility: 
country: France
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
sharing ipd: No