Female Aneurysm Screening STudy

NCT03277781 | Completed

• 3 other identifiers: 05732016-001261-83PB-PG-0215-36027
• Study Type: observational
• Target: 5,612
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Attendance

  Proportion of women attending for AAA screening

  Day 1

• Prevalence

  Proportion of women who attend for screening who have an AAA

  Day 1

Study Arms (3)

Current smokers

Other: Screening

Ex-smokers

Other: Screening

Coronary heart disease

Other: Screening

Interventions

Screening OTHER

Screening for AAA

Coronary heart disease; Current smokers; Ex-smokers

Eligibility Criteria

• Age: 65 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

White women aged 65 to 74 with a history of smoking and/or coronary heart disease

You may qualify if:

• As per group definitions

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leicester: lead
• University of Cambridge: collaborator

Study Sites (1)

University Hospitals of Leicester

Leicester, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: September 11, 2017
• Study Start: November 1, 2016
• Primary Completion: May 28, 2019
• Study Completion: May 28, 2019
• Last Updated: January 30, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)