Ignite Creation Date:
2024-05-06 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05230264
Status:
UNKNOWN
Last Update Posted:
2022-02-08
First Post:
2022-01-18
Brief Title:
Sex-specific Differences in the Stress Response to Abdominal Aortic Aneurysm Repair
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Examination of Sex-specific Differences in the Stress Response to Abdominal Aortic Aneurysm Repair - A Prospective Cohort Study
Status:
UNKNOWN
Status Verified Date:
2022-01
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:
SSStressAAA
Brief Summary:
It is recognised that women are at greater risk of death complications and longer hospital stay following intact abdominal aortic aneurysm AAA repair and the reason for this is not yet established This disparity in outcomes for women compared to men is also recognised in other forms of cardiovascular surgery which raises the question of whether women and men are reacting differently to the stress of operative repair
This study aims to examine whether there are differences baseline stress markers and in the stress response to AAA repair between men and women It will also examine whether markers of stress are associated with poor clinical outcomes and slower recovery indicated by longer hospital stay
The study will take the form of an observational cohort study It will not alter any of the treatment that men and women receive but will monitor their stress levels using physiological markers through ECG electrocardiogram monitoring using a non-invasive holter biochemical markers using blood samples which will be taken at the same time as routine testing so as not to require further invasive procedures and psychological testing using short forms that the patient will be able to fill out independently at different stages of their recovery Clinical data will be used to look for relevant factors clinical history or medications which may alter the stress markers we are observing and to compare outcomes with markers of stress
Patients will be asked for their consent to share their data with the research team in order to participate in the study It will be made clear that there will be no change in their clinical or operative management if they participate in the study and they will be able to withdraw consent for further participation at any time
This study aims to examine whether there are differences baseline stress markers and in the stress response to AAA repair between men and women It will also examine whether markers of stress are associated with poor clinical outcomes and slower recovery indicated by longer hospital stay
The study will take the form of an observational cohort study It will not alter any of the treatment that men and women receive but will monitor their stress levels using physiological markers through ECG electrocardiogram monitoring using a non-invasive holter biochemical markers using blood samples which will be taken at the same time as routine testing so as not to require further invasive procedures and psychological testing using short forms that the patient will be able to fill out independently at different stages of their recovery Clinical data will be used to look for relevant factors clinical history or medications which may alter the stress markers we are observing and to compare outcomes with markers of stress
Patients will be asked for their consent to share their data with the research team in order to participate in the study It will be made clear that there will be no change in their clinical or operative management if they participate in the study and they will be able to withdraw consent for further participation at any time
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