Female Aneurysm Screening STudy

NCT ID: NCT03277781

Last Updated: 2020-01-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5612 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2019-05-28

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.

Conditions

Abdominal Aortic Aneurysm

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Current smokers

Screening

Intervention Type: OTHER

Screening for AAA

Ex-smokers

Screening

Intervention Type: OTHER

Screening for AAA

Coronary heart disease

Screening

Intervention Type: OTHER

Screening for AAA

Interventions

Screening

Screening for AAA

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Cambridge

OTHER

Sponsor Role: collaborator

University of Leicester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospitals of Leicester

Leicester, , United Kingdom

Countries

United Kingdom

Other Identifiers

2016-001261-83

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PB-PG-0215-36027

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

0573

Identifier Type: -

Identifier Source: org_study_id