Abdominal Aortic AneurysmSSStressAAANCT05230264
Sex-specific Differences in the Stress Response to Abdominal Aortic Aneurysm Repair
An observational study of Abdominal Aortic Aneurysm and Stress, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Abdominal Aortic Aneurysm, Stress, Surgery
- What is being tested?
- Elective AAA Repair
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2022to 1 Oct 2023
- 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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women undergoing primary elective intact AAA repair, open or endovascular (EVAR) at participating centres. Consecutive recruitment.
Who may be able to join
- Men and women undergoing primary elective intact AAA repair, open or endovascular (EVAR) at participating centres.
- Capacity to consent.
Who cannot join
- Participants undergoing a secondary or emergency aortic procedure, or procedure for alternative aortic pathology.
- Relevant confounding pathology such as hypothalamic-pituitary axis pathology (e.g. Addison's disease).
- Lack of capacity to consent.
- Participants with pacemaker dependency, or a significant arrhythmia, will be excluded from analysis of heart rate variability, but will be included in the study for analysis of psychological and biochemical markers of stress.
- Participants on steroid treatment will also be excluded from analysis of biochemical markers but may be included for analysis of physiological markers and/or heart rate variability.
- Participants must be over the age of 50 (In order to facilitate capture of degenerative aortic aneurysmal pathology rather than an alternative aortic pathology e.g. traumatic, connective tissue disorder).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College London
London
Colin Bicknell
Anna L Pouncey
About this study
Official title: Examination of Sex-specific Differences in the Stress Response to Abdominal Aortic Aneurysm Repair - A Prospective Cohort Study
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).
Read more
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.
- Conditions
- Abdominal Aortic Aneurysm, Stress, Surgery
- Being tested
- Elective AAA Repair
- 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.
Elective AAA RepairOther
Elective AAA Repair - Observation of Stress Response
| Study group | Role | What they receive |
|---|---|---|
| Men | Elective AAA Repair Receives: Other: Elective AAA Repair | |
| Women | Elective AAA Repair Receives: Other: Elective AAA Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical measures of stress: level of serum cortisol & dehydroepiandrosterone (DHEA)
Sex-specific differences in baseline and timing/magnitude of response to operative stress.
Measured: Samples taken on the morning of operation (baseline), at anaesthetic induction, at the end of the procedure, 6 hours post-procedure and early morning samples during the remaining inpatient stay.
Secondary outcomes (2)
Physiological parameters: assessment of beat-to-beat heart rate variability metrics.
Sex-specific differences in baseline and timing/magnitude of response to operative stress.
Measured: Baseline recording compared to post-operative recording of patient recovery during inpatient stay.
Psychological measures of stress: measured by State Trait Anxiety Inventory-Y and self assessment (Likert Scale).
Sex-specific differences in the baseline and timing/magnitude of response to operative stress.
Measured: Pre-operative assessment compared to post-operative assessment at specified intervals during operative recovery - 2, 14, 30 and 90 days post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Feb 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230264
- Sponsor's protocol ID
- 21SM7254
- Acronym
- SSStressAAA
- Status last verified
- Jan 2022
- First submitted
- 18 Jan 2022
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Sex-specific Differences in the Stress Response to Abdominal Aortic Aneurysm Repair - A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05230264
- Acronym / sponsor ID
- SSStressAAA / 21SM7254
- Conditions
- Abdominal Aortic Aneurysm, Stress, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 8 Feb 2022 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men | – | Other: Elective AAA RepairElective AAA Repair |
| Women | – | Other: Elective AAA RepairElective AAA Repair |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women undergoing primary elective intact AAA repair, open or endovascular (EVAR) at participating centres. Consecutive recruitment.
Key inclusion criteria (2 listed)
- Men and women undergoing primary elective intact AAA repair, open or endovascular (EVAR) at participating centres.
- Capacity to consent.
Key exclusion criteria (6 listed)
- Participants undergoing a secondary or emergency aortic procedure, or procedure for alternative aortic pathology.
- Relevant confounding pathology such as hypothalamic-pituitary axis pathology (e.g. Addison's disease).
- Lack of capacity to consent.
- Participants with pacemaker dependency, or a significant arrhythmia, will be excluded from analysis of heart rate variability, but will be included in the study for analysis of psychological and biochemical markers of stress.
- Participants on steroid treatment will also be excluded from analysis of biochemical markers but may be included for analysis of physiological markers and/or heart rate variability.
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 |
|---|---|---|
| Elective AAA RepairElective AAA Repair - Observation of Stress Response | Other | Men, Women |
Primary outcome
Biochemical measures of stress: level of serum cortisol & dehydroepiandrosterone (DHEA)
Time frame: Samples taken on the morning of operation (baseline), at anaesthetic induction, at the end of the procedure, 6 hours post-procedure and early morning samples during the remaining inpatient stay.
Sex-specific differences in baseline and timing/magnitude of response to operative stress.
2 secondary outcomes
Physiological parameters: assessment of beat-to-beat heart rate variability metrics.
Time frame: Baseline recording compared to post-operative recording of patient recovery during inpatient stay.
Psychological measures of stress: measured by State Trait Anxiety Inventory-Y and self assessment (Likert Scale).
Time frame: Pre-operative assessment compared to post-operative assessment at specified intervals during operative recovery - 2, 14, 30 and 90 days post-operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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 Abdominal Aortic Aneurysm and Stress, run by Imperial College London 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 2 inclusion and 6 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 8 Feb 2022. 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?
Biochemical measures of stress: level of serum cortisol & dehydroepiandrosterone (DHEA) (time frame: Samples taken on the morning of operation (baseline), at anaesthetic induction, at the end of the procedure, 6 hours post-procedure and early morning samples during the remaining inpatient stay.). 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 8 Feb 2022.