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NHS AAA Screening Programme Data Linkage With HES and ONS Datasets

NCT03407664 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000000

Last updated 2020-03-10

No results posted yet for this study

Summary

An abdominal aortic aneurysm (AAA) is a dilation of the aorta, defined as an aortic diameter of ≥3cm. It is a significant cause of death internationally and in England each year causes c.4,000 deaths with 8,000 patients undergoing preventative surgery. AAA are often asymptomatic and there is a latent period between development and rupture. This represents an opportunity to screen by ultrasound which has been shown in trials to reduce AAA related mortality by half.

In England this evidence is based on a randomised trial data from the late nineties, however, since these data were published the number of men identified with AAA has fallen to a current prevalence of just over 1%. Furthermore, similarly designed randomised trials in Western Australia demonstrated no meaningful differences in AAA or cardiovascular deaths. The first aim of our research is to follow men who have been screened for AAA in England in order to establish the medium (5 years) and long term (10+ years) impact of AAA screening on the risk of a AAA, cardiovascular and all-cause morbidity/mortality in a non-trial setting. Men with sub-aneurysms will be examined (Aorta=2.5-2.9cm) as several studies suggest this group is at risk of late rupture.

The role of patient pathways to improve uptake of the screening programme will be examined. Current data suggests that the most 'deprived' men in England are the least likely to turn up for screening but the most likely to have an abdominal aneurysm. Outcomes in this group will be analysed including the benefit of a new patient pathway to improve uptake nationally.

Lastly, several large studies have demonstrated that a larger aortic diameter may be associated with cardiovascular risk. The addition of aortic diameter to current risk prediction models could improve the accuracy of these models and will be examined.

Conditions

  • AAA

Interventions

OTHER

this field is not applicable

We will not be testing an intervention. Only the long term outcomes of men screened for AAA in England.

Sponsors & Collaborators

  • University of Leicester

    lead OTHER

Eligibility

Min Age
65 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2021-01-01
Completion
2021-01-01

Countries

  • United Kingdom

Study Locations

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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 NCT03407664 on ClinicalTrials.gov