AAANCT03407664
NHS AAA Screening Programme Data Linkage With HES and ONS Datasets
An observational study of AAA, run by University of Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 65 years, men only
- Conditions the study is for
- AAA
- What is being tested?
- this field is not applicable
- How many people
- 1,000,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2020to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 65 years
- Men only
- Older adult
Study population: Men screened for AAA within the NHS AAA Screening programme in England for the period covering 2013-2017; specifically, screening years 2013/14, 2014/15, 2015/16 and 2016/17.
Who may be able to join
- All men invited to the NHS AAA screening programme in England between the period of 2013-2017
- Aged 65 years of age at the time of their invitation to the NHS AAA screening programme
- All men who have consented for their data to be used for the purposes of research
Who cannot join
- 1. All men who do not consent for their data to be used for the purposes of research
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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 (≤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 13,104 whom do not require early surgery.
The incidence of AAA is falling in western populations likely secondary to a reduction in the number of individuals smoking cigarettes in addition to other pharmacological (increase in the use of anti-platelets and statins) and lifestyle (exercise) modifications. This reduction in the number of men with AAA raises the question of whether in the long term community AAA screening will remain cost effective, however, to examine cost effectiveness it is important to establish what happens to all men invited to AAA screening over time. One aspect of this is examining the long term outcomes of men who have an aortic diameter above 3.0cm whilst another highly debated topic is the outcome of men with an aortic diameter between 2.5-2.9cm which may be defined as sub-aneurysmal. This group of men have been demonstrated to be at risk of developing AAA in later life (over 10 years) and there is a risk that these discharged men later go on to be at risk of aneurysm rupture.
the study would also like to examine the impact of deprivation on uptake of the screening programme is England. Uptake of the screening programme in 2015-2016 was 85.4%, however this varies from 76.6% in Merseyside to 92.0% in less deprived parts of England. Previous studies have highlighted the association between social deprivation and poor uptake and pilot data from our study suggests that this deprived group are also more likely to have an abdominal aneurysm. This puts this group at great risk without the benefit of screening to prevent rupture. Within this study outcomes in this group (AAA related death, admission and all-cause mortality/morbidity) will be assessed in order to accurately assess the cost benefit of new patient pathways to improve AAA screening uptake in the most deprived group.
Lastly, over time NAAASP will detect a large number of patients with small aneurysms that will require regular surveillance. Patients with AAA are widely recognized to be at a higher cardiovascular risk then the general population for example one recent systematic review identified a strong link between cardiovascular death and time from diagnosis of small AAA with a 3% increased risk of cardiovascular mortality per year compared with the general population. Duncan and Colleagues also described long term outcomes of men screened for AAA in Scotland finding that the most common cause of death in those with AAA was cardiovascular disease and that this risk increases with aortic diameter. Increasing aortic diameter and poor cardiovascular outcomes have also been noted in several other large cohort studies.
Aortic Diameter may be an independent marker of cardiovascular risk that could improve the sensitivity of current cardiovascular risk prediction models used commonly in England. Screening may also be an opportunity to identify men at higher cardiovascular risk (both with an aneurysm and without) creating added benefit to the screening programme. None the less contemporary data suggests that cardiovascular risk is inadequately addressed in this high risk cohort and requires further study.
- Conditions
- AAA
- Being tested
- this field is not applicable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
this field is not applicableOther
We will not be testing an intervention. Only the long term outcomes of men screened for AAA in England.
| Study group | Role | What they receive |
|---|---|---|
| Men Screened for AAA in England | Men invited into the NHS AAA Screening programme in England in the years 2013-2017. Receives: Other: this field is not applicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
AAA related mortality in men invited for AAA screening
Mortality
Measured: 10 years
AAA related morbidity in men invited for AAA screening
Admissions to Hospital
Measured: 10 years
Secondary outcomes (3)
Medium term mortality
Mortality (number of deaths)
Measured: 5 years
Cardiovascular risk in men screened for AAA
Combined events (mortality and morbidity)
Measured: 10 years
Medium term morbidity
Admissions to Hospital
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Jul 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AAAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407664
- Sponsor's protocol ID
- 0652
- Status last verified
- Jan 2020
- First submitted
- 13 Dec 2017
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be anonymised and no patient data will be passed outside of the research group. Results will be published in the usual way.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NHS AAA Screening Programme Data Linkage With HES and ONS Datasets
- ClinicalTrials.gov ID
- NCT03407664
- Acronym / sponsor ID
- 0652
- Conditions
- AAA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (≤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 13,104 whom do not require early surgery.
The incidence of AAA is falling in western populations likely secondary to a reduction in the number of individuals smoking cigarettes in addition to other pharmacological (increase in the use of anti-platelets and statins) and lifestyle (exercise) modifications. This reduction in the number of men with AAA raises the question of whether in the long term community AAA screening will remain cost effective, however, to examine cost effectiveness it is important to establish what happens to all men invited to AAA screening over time. One aspect of this is examining the long term outcomes of men who have an aortic diameter above 3.0cm whilst another highly debated topic is the outcome of men with an aortic diameter between 2.5-2.9cm which may be defined as sub-aneurysmal. This group of men have been demonstrated to be at risk of developing AAA in later life (over 10 years) and there is a risk that these discharged men later go on to be at risk of aneurysm rupture.
the study would also like to examine the impact of deprivation on uptake of the screening programme is England. Uptake of the screening programme in 2015-2016 was 85.4%, however this varies from 76.6% in Merseyside to 92.0% in less deprived parts of England. Previous studies have highlighted the association between social deprivation and poor uptake and pilot data from our study suggests that this deprived group are also more likely to have an abdominal aneurysm. This puts this group at great risk without the benefit of screening to prevent rupture. Within this study outcomes in this group (AAA related death, admission and all-cause mortality/morbidity) will be assessed in order to accurately assess the cost benefit of new patient pathways to improve AAA screening uptake in the most deprived group.
Lastly, over time NAAASP will detect a large number of patients with small aneurysms that will require regular surveillance. Patients with AAA are widely recognized to be at a higher cardiovascular risk then the general population for example one recent systematic review identified a strong link between cardiovascular death and time from diagnosis of small AAA with a 3% increased risk of cardiovascular mortality per year compared with the general population. Duncan and Colleagues also described long term outcomes of men screened for AAA in Scotland finding that the most common cause of death in those with AAA was cardiovascular disease and that this risk increases with aortic diameter. Increasing aortic diameter and poor cardiovascular outcomes have also been noted in several other large cohort studies.
Aortic Diameter may be an independent marker of cardiovascular risk that could improve the sensitivity of current cardiovascular risk prediction models used commonly in England. Screening may also be an opportunity to identify men at higher cardiovascular risk (both with an aneurysm and without) creating added benefit to the screening programme. None the less contemporary data suggests that cardiovascular risk is inadequately addressed in this high risk cohort and requires further study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men Screened for AAA in England | – | Other: this field is not applicableMen invited into the NHS AAA Screening programme in England in the years 2013-2017. |
Who may qualify
- Ages
- 65 to 65 years
- Sex
- Male only
- Age groups
- Older adult
- Study population
- Men screened for AAA within the NHS AAA Screening programme in England for the period covering 2013-2017; specifically, screening years 2013/14, 2014/15, 2015/16 and 2016/17.
Key inclusion criteria (3 listed)
- All men invited to the NHS AAA screening programme in England between the period of 2013-2017
- Aged 65 years of age at the time of their invitation to the NHS AAA screening programme
- All men who have consented for their data to be used for the purposes of research
Key exclusion criteria (1 listed)
- 1. All men who do not consent for their data to be used for the purposes of research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| this field is not applicableWe will not be testing an intervention. Only the long term outcomes of men screened for AAA in England. | Other | Men Screened for AAA in England |
Primary outcome
AAA related mortality in men invited for AAA screening
Time frame: 10 years
Mortality
AAA related morbidity in men invited for AAA screening
Time frame: 10 years
Admissions to Hospital
3 secondary outcomes
Medium term mortality
Time frame: 5 years
Cardiovascular risk in men screened for AAA
Time frame: 10 years
Medium term morbidity
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: No. Data will be anonymised and no patient data will be passed outside of the research group. Results will be published in the usual way.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AAA, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AAA related mortality in men invited for AAA screening (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.