Ignite Creation Date:
2024-05-06 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03365050
Status:
UNKNOWN
Last Update Posted:
2021-05-03
First Post:
2017-11-27
Brief Title:
A Study of the Safety of Targeted AAA Screening
Sponsor:
University of Leicester
Organization:
University of Leicester
Study Overview
Official Title:
Data Linkage Between NHS AAA Screening Programme and Primary Care Data to Determine the Safety of a Targeted Screening Programme
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 55cm are referred for consideration of surgery whilst men with small AAA 54cm are referred into surveillance 30-44cm 1 year surveillance 45-54cm 3 months surveillance as per standard operating procedures In England 284583 men were offered ultrasound screening 2015-2016 however the number of men identified with AAA was 2549 at a cost of approximately 7755000 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 131047 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 US 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
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 US 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None