Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03365050 |
| Other study ID # |
0635 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2021 |
| Est. completion date |
September 30, 2024 |
Study information
| Verified date |
April 2021 |
| Source |
University of Leicester |
| Contact |
Matthew Bown, PhD |
| Phone |
0116 204 |
| Email |
mjb42[@]le.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study is a data linkage project within which we aim to model the impact on the NHS AAA
Screening programme of a targeted approach to screening by targeting men who smoke. This
in-silico study will generate a hypothetical population based on primary care datasets with
known outcomes from screening (we know which men have an aneurysm and who do not) to
determine the feasibility and safety of this approach.
Description:
An abdominal aortic aneurysm (AAA) is present in 5-10% of men aged between 65 and 79 years
and may be defined as an abdominal aortic diameter 3cm or above. In 2013 the NHS AAA
screening programme (NAAASP) was fully rolled out across England with the aim of reducing AAA
mortality in men aged 65 and over, based on evidence that screening reduces AAA-related
mortality, and is highly cost effective. Within NAAASP, men with a large AAA (≤5.5cm) are
referred for consideration of surgery whilst men with small AAA (≥5.4cm) are referred into
surveillance (3.0-4.4cm: 1 year surveillance, 4.5-5.4cm: 3 months surveillance) as per
standard operating procedures. In England 284,583 men were offered ultrasound screening
(2015-2016), however, the number of men identified with AAA was 2,549 at a cost of
approximately £7,755,000. This highlights one of the main problems with AAA screening in that
the majority of men screened do not have disease. This also brought the number of men within
AAA surveillance to 13,1047 whom do not require early surgery.
Several studies have investigated quality of life (QoL) in those who are screened for AAA,
with one reporting short-term decreases in QoL at 1 year and four demonstrating no clinically
important decrease in QoL in those screened positive compared with an unscreened control
group. This has raised the issue of harms versus benefit however, AAA screening is not the
same worldwide. For example, within The U.S. Preventive Services Task Force AAA Screening is
recommended only for men aged 65-75 who have ever smoked as this group "stands to benefit the
most from early detection and reparative surgical treatment due to a relatively higher
prevalence of larger AAAs" . The screening programme described thus deemed men who have never
smoked as lower risk for AAA and lower risk for rupture yet in England, we screen every man
at the age of 65.
Although several risk factors for AAA have been identified, smoking is the only modifiable
risk factor that has been associated with the development, expansion and rupture of AAA with
a causative link revealed in vivo within a mouse model. Population based studies have also
demonstrated that smoking prevalence over time is linked to changes in AAA mortality. It is
possible that screening based on a history of smoking is feasible and safe, however, no
evidence exists that this would be the case. In England details for men eligible for AAA
screening is identified based on primary care data in that men registered with a General
Practitioner (GP) who are 65 within that year are invited to screening. Primary care data may
also be able to identify men with a history of smoking and other known risk factors for AAA
including hypertension, heart disease and stroke.
