NCT03277781: FAST

Female Aneurysm Screening STudy

Completed Last updated 30 January 2020

What this trial tests

trial testing Screening in Abdominal Aortic Aneurysm in 5,612 participants. Completed in 28 May 2019.

Timeline

1 November 2016

Primary endpoint
28 May 2019

28 May 2019

Quick facts

Lead sponsor	University of Leicester
Status	Completed
Study type	OBSERVATIONAL
Enrollment	5,612
Start date	1 November 2016
Primary completion	28 May 2019
Estimated completion	28 May 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• Screening

Conditions studied

• Abdominal Aortic Aneurysm — all drugs for Abdominal Aortic Aneurysm →

Sponsor

University of Leicester

Who can join

Adults 65 to 74, female only, with Abdominal Aortic Aneurysm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Ultrasound screening for abdominal aortic aneurysm in high-risk women.
   Duncan A, Maslen C, Gibson C, Hartshorne T, et al · · 2021 · cited 23× · PMID 34370826 · DOI 10.1093/bjs/znab220