Brief Title
Female Aneurysm Screening STudy
Official Title
Female Aneurysm Screening STudy
Brief Summary
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.
Study Type
Observational
Primary Outcome
Attendance
Condition
Abdominal Aortic Aneurysm
Intervention
Screening
Study Arms / Comparison Groups
Current smokers
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
5612
Start Date
November 1, 2016
Completion Date
May 28, 2019
Primary Completion Date
May 28, 2019
Eligibility Criteria
Inclusion Criteria:
- As per group definitions
Exclusion Criteria:
- Any significant disease or disorder which, in the opinion of the Investigator or the
patient's general practitioner, may either put the participants at risk because of
participation in the study, or may influence the result of the study, or the
participant's ability to participate in the study.
Gender
Female
Ages
65 Years - 74 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT03277781
Organization ID
0573
Secondary IDs
2016-001261-83
Responsible Party
Sponsor
Study Sponsor
University of Leicester
Collaborators
University of Cambridge
Study Sponsor
, ,
Verification Date
September 2019