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Female Aneurysm Screening STudy

NCT03277781 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5612

Last updated 2020-01-30

No results posted yet for this study

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.

Conditions

  • Abdominal Aortic Aneurysm

Interventions

OTHER

Screening

Screening for AAA

Sponsors & Collaborators

Eligibility

Min Age
65 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2019-05-28
Completion
2019-05-28

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03277781 on ClinicalTrials.gov