NCT03365050

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
4 years until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

2.8 years

First QC Date

November 27, 2017

Last Update Submit

April 29, 2021

Conditions

AAA - Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

  • death from AAA after screening

    AAA-related mortality after screening based on ONS ICD codes

    long term mortality - 10 years

Secondary Outcomes (3)

  • cost effectiveness analysis

    long term - 10 years

  • Feasibility of targeted screening

    1 year

  • All-Cause mortality.

    long term mortality - 10 years

Interventions

No Intervention GivenOTHER

No Intervention to be given

Eligibility Criteria

Age65 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men aged 65 who are invited for AAA screening in England.

You may qualify if:

  • All men invited into the English AAA Screening Programme

You may not qualify if:

  • All men not within the screening programme or who dissent from their data being used for research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leicester

Leicester, LE3 9QP, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Central Study Contacts

Matthew Bown, PhD

CONTACT

0116 204mjb42@le.ac.uk

David Sidloff, MD

CONTACT

0116 204ds343@le.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 7, 2017

Study Start

December 1, 2021

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

May 3, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)