Ignite Creation Date:
2024-05-06 @ 10:30 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03277781
Status:
COMPLETED
Last Update Posted:
2020-01-30
First Post:
2017-08-29
Brief Title:
Female Aneurysm Screening STudy
Sponsor:
University of Leicester
Organization:
University of Leicester
Study Overview
Official Title:
Female Aneurysm Screening STudy
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
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:
FAST
Brief Summary:
An abdominal aortic aneurysm AAA is a swelling of the main blood vessel aorta in the abdomen If the swelling gets too large the aorta can burst and this is usually fatal In order to prevent rupture AAA can be surgically repaired This is usually carried out when the size of the AAA is more than 55cm in diameter as below this size the risk of rupture is lower than the risk of surgery AAA are usually asymptomatic before rupture but can easily and safely be diagnosed by ultrasound scanning There is currently a national screening programme for men but not women
Women are not screened for AAA on the basis that the disease is less common in females However 336 of all deaths caused by ruptured AAA in England and Wales are in females 1109 female deaths1 Death rates due to ruptured AAA in men have nearly halved over the last decade but the reduction in female deaths over the same time period is less than one third Females with AAA are also 4-times more likely to rupture their aneurysm and have higher rates of complications and death after emergency surgery than men
There are groups of females such as smokers who are at high risk of AAA The investigators have identified risk factors that are easily identifiable from general practice databases that may be able to identify women at high risk of AAA In this research it will be determined whether it is feasible to select women for AAA screening using these risk factors how many women in these high-risk groups attend if they are invited for AAA screening and screen women to determine the numbers in the different risk groups who have AAA This will allow the assessment of whether screening women for AAA could be clinically or cost effective and who would benefit the most The investigators will also investigate if the siblings of patients with AAAs are at higher risk of disease by inviting them for screening too
Women are not screened for AAA on the basis that the disease is less common in females However 336 of all deaths caused by ruptured AAA in England and Wales are in females 1109 female deaths1 Death rates due to ruptured AAA in men have nearly halved over the last decade but the reduction in female deaths over the same time period is less than one third Females with AAA are also 4-times more likely to rupture their aneurysm and have higher rates of complications and death after emergency surgery than men
There are groups of females such as smokers who are at high risk of AAA The investigators have identified risk factors that are easily identifiable from general practice databases that may be able to identify women at high risk of AAA In this research it will be determined whether it is feasible to select women for AAA screening using these risk factors how many women in these high-risk groups attend if they are invited for AAA screening and screen women to determine the numbers in the different risk groups who have AAA This will allow the assessment of whether screening women for AAA could be clinically or cost effective and who would benefit the most The investigators will also investigate if the siblings of patients with AAAs are at higher risk of disease by inviting them for screening too
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PB-PG-0215-36027 | OTHER_GRANT | NIHR | None |
| 2016-001261-83 | EUDRACT_NUMBER | None | None |