Female Aneurysm Screening STudy

Abdominal Aortic Aneurysm Clinical Trial

— FAST  

Official title:

Female Aneurysm Screening STudy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03277781
• Other study ID #: 0573
• Secondary ID: 2016-001261-83PB
• Status: Completed
• Start date: November 1, 2016
• Est. completion date: May 28, 2019

Study information

• Verified date: September 2019
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5612
• Est. completion date: May 28, 2019
• Est. primary completion date: May 28, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Other:
• Screening
Screening for AAA

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester	Leicester

Sponsors (2)

Lead Sponsor	Collaborator
University of Leicester	University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attendance	Proportion of women attending for AAA screening	Day 1
Primary	Prevalence	Proportion of women who attend for screening who have an AAA	Day 1