<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/NCT03277781</url>
  </required_header>
  <id_info>
    <org_study_id>0573</org_study_id>
    <secondary_id>2016-001261-83</secondary_id>
    <secondary_id>PB-PG-0215-36027</secondary_id>
    <nct_id>NCT03277781</nct_id>
  </id_info>
  <brief_title>Female Aneurysm Screening STudy</brief_title>
  <acronym>FAST</acronym>
  <official_title>Female Aneurysm Screening STudy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leicester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Cambridge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Leicester</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>
      An abdominal aortic aneurysm (AAA) is a swelling of the main blood vessel (aorta) in the&#xD;
      abdomen. If the swelling gets too large the aorta can burst and this is usually fatal. In&#xD;
      order to prevent rupture, AAA can be surgically repaired. This is usually carried out when&#xD;
      the size of the AAA is more than 5.5cm in diameter as below this size, the risk of rupture is&#xD;
      lower than the risk of surgery. AAA are usually asymptomatic before rupture but can easily&#xD;
      and safely be diagnosed by ultrasound scanning. There is currently a national screening&#xD;
      programme for men, but not women.&#xD;
&#xD;
      Women are not screened for AAA on the basis that the disease is less common in females.&#xD;
      However, 33.6% of all deaths caused by ruptured AAA in England and Wales are in females (1109&#xD;
      female deaths)1. Death rates due to ruptured AAA in men have nearly halved over the last&#xD;
      decade but the reduction in female deaths over the same time period is less than one third.&#xD;
      Females with AAA are also 4-times more likely to rupture their aneurysm and have higher rates&#xD;
      of complications and death after emergency surgery than men.&#xD;
&#xD;
      There are groups of females such as smokers, who are at high risk of AAA. The investigators&#xD;
      have identified risk factors that are easily identifiable from general practice databases&#xD;
      that may be able to identify women at high risk of AAA. In this research it will be&#xD;
      determined whether it is feasible to select women for AAA screening using these risk factors,&#xD;
      how many women in these high-risk groups attend if they are invited for AAA screening, and&#xD;
      screen women to determine the numbers in the different risk groups who have AAA. This will&#xD;
      allow the assessment of whether screening women for AAA could be clinically or cost effective&#xD;
      and who would benefit the most. The investigators will also investigate if the siblings of&#xD;
      patients with AAAs are at higher risk of disease by inviting them for screening too.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2016</start_date>
  <completion_date type="Actual">May 28, 2019</completion_date>
  <primary_completion_date type="Actual">May 28, 2019</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>Attendance</measure>
    <time_frame>Day 1</time_frame>
    <description>Proportion of women attending for AAA screening</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence</measure>
    <time_frame>Day 1</time_frame>
    <description>Proportion of women who attend for screening who have an AAA</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">5612</enrollment>
  <condition>Abdominal Aortic Aneurysm</condition>
  <arm_group>
    <arm_group_label>Current smokers</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Ex-smokers</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Coronary heart disease</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Screening</intervention_name>
    <description>Screening for AAA</description>
    <arm_group_label>Coronary heart disease</arm_group_label>
    <arm_group_label>Current smokers</arm_group_label>
    <arm_group_label>Ex-smokers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        White women aged 65 to 74 with a history of smoking and/or coronary heart disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  As per group definitions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any significant disease or disorder which, in the opinion of the Investigator or the&#xD;
             patient's general practitioner, may either put the participants at risk because of&#xD;
             participation in the study, or may influence the result of the study, or the&#xD;
             participant's ability to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospitals of Leicester</name>
      <address>
        <city>Leicester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>January 29, 2020</last_update_submitted>
  <last_update_submitted_qc>January 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2020</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>Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm</mesh_term>
    <mesh_term>Aortic Aneurysm, Abdominal</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/NCT03277781
org study id: 0573
secondary id: 2016-001261-83
secondary id: PB-PG-0215-36027
nct id: NCT03277781
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An abdominal aortic aneurysm (AAA) is a swelling of the main blood vessel (aorta) in the
      abdomen. If the swelling gets too large the aorta can burst and this is usually fatal. In
      order to prevent rupture, AAA can be surgically repaired. This is usually carried out when
      the size of the AAA is more than 5.5cm in diameter as below this size, the risk of rupture is
      lower than the risk of surgery. AAA are usually asymptomatic before rupture but can easily
      and safely be diagnosed by ultrasound scanning. There is currently a national screening
      programme for men, but not women.

      Women are not screened for AAA on the basis that the disease is less common in females.
      However, 33.6% of all deaths caused by ruptured AAA in England and Wales are in females (1109
      female deaths)1. Death rates due to ruptured AAA in men have nearly halved over the last
      decade but the reduction in female deaths over the same time period is less than one third.
      Females with AAA are also 4-times more likely to rupture their aneurysm and have higher rates
      of complications and death after emergency surgery than men.

      There are groups of females such as smokers, who are at high risk of AAA. The investigators
      have identified risk factors that are easily identifiable from general practice databases
      that may be able to identify women at high risk of AAA. In this research it will be
      determined whether it is feasible to select women for AAA screening using these risk factors,
      how many women in these high-risk groups attend if they are invited for AAA screening, and
      screen women to determine the numbers in the different risk groups who have AAA. This will
      allow the assessment of whether screening women for AAA could be clinically or cost effective
      and who would benefit the most. The investigators will also investigate if the siblings of
      patients with AAAs are at higher risk of disease by inviting them for screening too.
observational model: Other
time perspective: Cross-Sectional
measure: Attendance
time frame: Day 1
description: Proportion of women attending for AAA screening
measure: Prevalence
time frame: Day 1
description: Proportion of women who attend for screening who have an AAA
arm group label: Current smokers
arm group label: Ex-smokers
arm group label: Coronary heart disease
intervention type: Other
intervention name: Screening
description: Screening for AAA
arm group label: Coronary heart disease
arm group label: Current smokers
arm group label: Ex-smokers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 65 Years
maximum age: 74 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Aneurysm
mesh term: Aortic Aneurysm
mesh term: Aortic Aneurysm, Abdominal
sharing ipd: No