AAA - Abdominal Aortic AneurysmNCT03365050
A Study of the Safety of Targeted AAA Screening
An observational study of AAA - Abdominal Aortic Aneurysm, run by University of Leicester at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 65 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- AAA - Abdominal Aortic Aneurysm
- How many people
- 1,000,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2021to 30 Sep 2024
- 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
- Healthy volunteers accepted
- Older adult
Study population: Men aged 65 who are invited for AAA screening in England.
Who may be able to join
- All men invited into the English AAA Screening Programme
Who cannot join
- All men not within the screening programme or who dissent from their data being used for research.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leicester
Leicester, LE3 9QP
Dr David Sidloff, MD, 4783, ds343@le.ac.uk
Dr Atanasios Saratzis, PhD, 4783, as875@leicester.ac.uk
About this study
Official title: Data Linkage Between NHS AAA Screening Programme and Primary Care Data to Determine the Safety of a Targeted Screening Programme.
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.
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 13,1047 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.
- Conditions
- AAA - Abdominal Aortic Aneurysm
- Being tested
- No Intervention Given
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention GivenOther
No Intervention to be given
What is being measured
The primary outcome is the main question the study is designed to answer.
death from AAA after screening
AAA-related mortality after screening based on ONS ICD codes
Measured: long term mortality - 10 years
Secondary outcomes (3)
cost effectiveness analysis
cost per QALY gained (cost-utility analysis) will be used to compare the current model of screening to a targeted model of screening as per NICE guidance.
Measured: long term - 10 years
Feasibility of targeted screening
Number of individuals identified with AAA in modelling study who have AAA at screening.
Measured: 1 year
All-Cause mortality.
Death after screening based on ONS ICD codes
Measured: long term mortality - 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Dec 2021 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AAA - Abdominal Aortic AneurysmStudies 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
- NCT03365050
- Sponsor's protocol ID
- 0635
- Status last verified
- Apr 2021
- First submitted
- 27 Nov 2017
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Linkage Between NHS AAA Screening Programme and Primary Care Data to Determine the Safety of a Targeted Screening Programme.
- ClinicalTrials.gov ID
- NCT03365050
- Acronym / sponsor ID
- 0635
- Conditions
- AAA - Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 7 Dec 2017 (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.
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 (≤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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Men aged 65 who are invited for AAA screening in England.
Key inclusion criteria (1 listed)
- All men invited into the English AAA Screening Programme
Key exclusion criteria (1 listed)
- All men not within the screening programme or who dissent from their data being used for 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 |
|---|---|---|
| No Intervention GivenNo Intervention to be given | Other | – |
Primary outcome
death from AAA after screening
Time frame: long term mortality - 10 years
AAA-related mortality after screening based on ONS ICD codes
3 secondary outcomes
cost effectiveness analysis
Time frame: long term - 10 years
Feasibility of targeted screening
Time frame: 1 year
All-Cause mortality.
Time frame: long term mortality - 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
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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.
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 - Abdominal Aortic Aneurysm, 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 1 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 3 May 2021. 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?
Contact Matthew Bown, PhD (0116 204 ext. 4783, mjb42@le.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death from AAA after screening (time frame: long term mortality - 10 years). 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 3 May 2021.