<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/NCT03250806</url>
  </required_header>
  <id_info>
    <org_study_id>FluClinic</org_study_id>
    <nct_id>NCT03250806</nct_id>
  </id_info>
  <brief_title>Early Detection of Aortic Stenosis in the Community During Flu Vaccination</brief_title>
  <acronym>FluClinic</acronym>
  <official_title>Early Detection of Aortic Stenosis in the Community: Role of Clinical and Echocardiographic Screening During Influenza Vaccination Multi-center, Prospective, Observational Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut für Pharmakologie und Präventive Medizin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut für Pharmakologie und Präventive Medizin</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>
      Prospective cohort study to test the hypothesis that patients identified with severe aortic&#xD;
      stenosis are under-diagnosed and under-treated. Such patients shall be identified by&#xD;
      auscultation or target echocardiography during flu vaccination. The hypothesis is that this&#xD;
      will increase detection of aortic stenosis in the community.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The design plans for two study phases:&#xD;
&#xD;
        1. Feasibility study: screening by auscultation and target echocardiography during flu&#xD;
           vaccination in a single practice in Birmingham;&#xD;
&#xD;
        2. Screening study: multi-centre screening by auscultation or target echocardiography in&#xD;
           geographically diverse general practices across the United Kingdom.&#xD;
&#xD;
      In each phase, the patient will be identified by auscultation and target echocardiography.&#xD;
      Management and onward referral will be at the clinical discretion of the GP. Results of&#xD;
      clinical review, investigation, follow-up and management will be recorded at 3 months from&#xD;
      that date.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">November 30, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</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>prevalence of aortic stenosis</measure>
    <time_frame>From date of examination until follow-up after three months</time_frame>
    <description>Determination of the prevalence of aortic stenosis detected on screening performed during flu vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>comparison of detection rate of aortic stenosis</measure>
    <time_frame>From date of examination until follow-up after three months</time_frame>
    <description>Comparison of detection rates of aortic stenosis using target auscultation vs detection by target 2D echocardiography.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of qualitative estimation of calcium burden on 2D echocardiography as a marker of AS severity</measure>
    <time_frame>three months</time_frame>
    <description>Method evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculation of costs in screening with auscultation versus target 2DE in screening for AS to inform future cost-efficacy studies of screening for AS.</measure>
    <time_frame>three months</time_frame>
    <description>Cost evaluation</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">167</enrollment>
  <condition>Aortic Stenosis</condition>
  <arm_group>
    <arm_group_label>newly identified aortic stenosis</arm_group_label>
    <description>Patients identified on auscultation or target echocardiography with aortic stenosis. Consecutive patients per centre with no limit to numbers.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients identified on auscultation or target echocardiography with aortic stenosis.&#xD;
        Consecutive patients per centre with no limit to numbers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged over 65years attending for influenza vaccination.&#xD;
&#xD;
          -  written informed consent to data collection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known aortic stenosis&#xD;
&#xD;
          -  previous aortic valve repair/replacement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Steeds, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Elizabeth Hospital, Birmingham, UK</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Bramlage, MD</last_name>
    <role>Study Chair</role>
    <affiliation>IPPMed UK Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Whaddon Medical Center</name>
      <address>
        <city>Milton Keynes</city>
        <state>Buckinghamshire</state>
        <zip>MK3 7QU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swanswell Medical Centre</name>
      <address>
        <city>Birmingham</city>
        <zip>B27 7AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>March 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>aortic stenosis, auscultation, target echocardiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</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/NCT03250806
org study id: FluClinic
nct id: NCT03250806
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective cohort study to test the hypothesis that patients identified with severe aortic
      stenosis are under-diagnosed and under-treated. Such patients shall be identified by
      auscultation or target echocardiography during flu vaccination. The hypothesis is that this
      will increase detection of aortic stenosis in the community.
The design plans for two study phases:

        1. Feasibility study: screening by auscultation and target echocardiography during flu
           vaccination in a single practice in Birmingham;

        2. Screening study: multi-centre screening by auscultation or target echocardiography in
           geographically diverse general practices across the United Kingdom.

      In each phase, the patient will be identified by auscultation and target echocardiography.
      Management and onward referral will be at the clinical discretion of the GP. Results of
      clinical review, investigation, follow-up and management will be recorded at 3 months from
      that date.
observational model: Cohort
time perspective: Prospective
measure: prevalence of aortic stenosis
time frame: From date of examination until follow-up after three months
description: Determination of the prevalence of aortic stenosis detected on screening performed during flu vaccination.
measure: comparison of detection rate of aortic stenosis
time frame: From date of examination until follow-up after three months
description: Comparison of detection rates of aortic stenosis using target auscultation vs detection by target 2D echocardiography.
measure: Evaluation of qualitative estimation of calcium burden on 2D echocardiography as a marker of AS severity
time frame: three months
description: Method evaluation
measure: Calculation of costs in screening with auscultation versus target 2DE in screening for AS to inform future cost-efficacy studies of screening for AS.
time frame: three months
description: Cost evaluation
arm group label: newly identified aortic stenosis
description: Patients identified on auscultation or target echocardiography with aortic stenosis. Consecutive patients per centre with no limit to numbers.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Richard Steeds, MD
role: Principal Investigator
affiliation: Queen Elizabeth Hospital, Birmingham, UK
last name: Peter Bramlage, MD
role: Study Chair
affiliation: IPPMed UK Ltd
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Constriction, Pathologic
sharing ipd: No