<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/NCT01679288</url>
  </required_header>
  <id_info>
    <org_study_id>ECO-AAA</org_study_id>
    <secondary_id>ECO-AAA-CAPSE</secondary_id>
    <nct_id>NCT01679288</nct_id>
  </id_info>
  <brief_title>Screening for Abdominal Aortic Aneurysm and Abdominal Aortic Atherosclerosis by Hand-Held Ultrasonography</brief_title>
  <acronym>ECO-AAA</acronym>
  <official_title>Feasibility of Hand-Held-Ultrasonography in Primary Care in the Screening of Abdominal Aortic Aneurysm and Abdominal Aortic Atheromatosis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Consorci d'Atenció Primària de Salut de l'Eixample</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Consorci d'Atenció Primària de Salut de l'Eixample</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the prevalence of abdominal aortic aneurysm (AAA)&#xD;
      and abdominal aortic atheromatosis (AA-At) using a hand-held ultrasound by a general&#xD;
      practitioner in Primary Health Care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pilot study that prospectively study a cohort of men over 50 years with cardiovascular risk&#xD;
      factors: active smokers, former smokers, or hypertensive patients, attended in primary health&#xD;
      care center. General Practitioner complete an ultrasonography training in an Ultrasound Unit&#xD;
      under supervision of experienced radiologists using an standard ultrasound equipment and&#xD;
      hand-held ultrasound (Trademark: VScan®, Manufacturer: General Electric, USA). All images and&#xD;
      video recorded are blindly evaluated by a radiologist in order to establish the concordance&#xD;
      in the interpretation of images between general practitioner and radiologist. Kappa index is&#xD;
      calculated to study the agreement on the presence or absence of AAA and AA-At. Logistic&#xD;
      regression analysis is used to determine the factors that influence the presence of AA-At&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">October 2011</completion_date>
  <primary_completion_date type="Actual">October 2011</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care.</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Hypertension</condition>
  <condition>Abdominal Aortic Aneurysm</condition>
  <condition>Atheromatosis</condition>
  <arm_group>
    <arm_group_label>ultrasound arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standardized measurements were made and aorta was tried to be visualized in its entirety, and a minimum of three hard copy images were obtained: upper transverse subxiphoid section, lower transverse section for distal view of aorta, and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound (Trademark:VScan; Manufacturer:General Electrics)</intervention_name>
    <description>Standardized measurements were made and aorta was tried to be visualized in its entirety, and a minimum of three hard copy images were obtained: upper transverse subxiphoid section, lower transverse section for distal view of aorta, and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm).</description>
    <arm_group_label>ultrasound arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Former smokers.&#xD;
&#xD;
          -  Hypertensive patients&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antoni Sisó Almirall, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consorci d'Atenció Primària de Salut de l'Eixample</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CAPSE</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.idibaps.org/research/7001/transverse-group-for-research-in-primary-care</url>
    <description>Research group's website</description>
  </link>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>June 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>October 15, 2014</last_update_submitted>
  <last_update_submitted_qc>October 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Consorci d'Atenció Primària de Salut de l'Eixample</investigator_affiliation>
    <investigator_full_name>Dr. Antoni Siso Almirall</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <keyword>Hand-Held ultrasonography</keyword>
  <keyword>Abdominal Aortic Aneurysm</keyword>
  <keyword>Abdominal Aortic Atherosclerosis</keyword>
  <keyword>Cardiovascular risk</keyword>
  <keyword>Primary Health Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</mesh_term>
  </condition_browse>
  <!-- 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/NCT01679288
org study id: ECO-AAA
secondary id: ECO-AAA-CAPSE
nct id: NCT01679288
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the prevalence of abdominal aortic aneurysm (AAA)
      and abdominal aortic atheromatosis (AA-At) using a hand-held ultrasound by a general
      practitioner in Primary Health Care.
Pilot study that prospectively study a cohort of men over 50 years with cardiovascular risk
      factors: active smokers, former smokers, or hypertensive patients, attended in primary health
      care center. General Practitioner complete an ultrasonography training in an Ultrasound Unit
      under supervision of experienced radiologists using an standard ultrasound equipment and
      hand-held ultrasound (Trademark: VScan®, Manufacturer: General Electric, USA). All images and
      video recorded are blindly evaluated by a radiologist in order to establish the concordance
      in the interpretation of images between general practitioner and radiologist. Kappa index is
      calculated to study the agreement on the presence or absence of AAA and AA-At. Logistic
      regression analysis is used to determine the factors that influence the presence of AA-At
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Number of patients with abdominal aortic aneurysm detected by a Hand-held ultrasound in Primary Care.
time frame: 24 months
measure: Number of patients with abdominal aortic atheromatosis detected by Hand-held ultrasound in Primary Care
time frame: 24 months
arm group label: ultrasound arm
arm group type: Experimental
description: Standardized measurements were made and aorta was tried to be visualized in its entirety, and a minimum of three hard copy images were obtained: upper transverse subxiphoid section, lower transverse section for distal view of aorta, and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm).
intervention type: Device
intervention name: Ultrasound (Trademark:VScan; Manufacturer:General Electrics)
description: Standardized measurements were made and aorta was tried to be visualized in its entirety, and a minimum of three hard copy images were obtained: upper transverse subxiphoid section, lower transverse section for distal view of aorta, and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm).
arm group label: ultrasound arm
criteria: 
gender: Male
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Antoni Sisó Almirall, MD PhD
role: Principal Investigator
affiliation: Consorci d'Atenció Primària de Salut de l'Eixample
facility: 
country: Spain
url: http://www.idibaps.org/research/7001/transverse-group-for-research-in-primary-care
description: Research group's website
responsible party type: Principal Investigator
investigator affiliation: Consorci d'Atenció Primària de Salut de l'Eixample
investigator full name: Dr. Antoni Siso Almirall
investigator title: MD PhD
mesh term: Aneurysm
mesh term: Atherosclerosis
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal