Sex-specific Differences in the Stress Response to Abdominal Aortic Aneurysm Repair

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Sex-specific Differences in the Stress Response to Abdominal Aortic Aneurysm Repair

Official Title

Examination of Sex-specific Differences in the Stress Response to Abdominal Aortic Aneurysm Repair - A Prospective Cohort Study

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.

Study Type

Observational

Primary Outcome

Biochemical measures of stress: level of serum cortisol & dehydroepiandrosterone (DHEA)

Secondary Outcome

 Physiological parameters: assessment of beat-to-beat heart rate variability metrics.

Condition

Abdominal Aortic Aneurysm

Intervention

Elective AAA Repair

Study Arms / Comparison Groups

 Men
Description:  Elective AAA Repair

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Other

Estimated Enrollment

60

Start Date

February 1, 2022

Completion Date

October 1, 2023

Primary Completion Date

October 1, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Men and women undergoing primary elective intact AAA repair, open or endovascular
             (EVAR) at participating centres.

          -  Capacity to consent.

        Exclusion Criteria:

          -  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).

Gender

All

Ages

50 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations

NCT ID

NCT05230264

Organization ID

21SM7254

Responsible Party

Sponsor

Study Sponsor

Imperial College London

Study Sponsor

, ,

Verification Date

January 2022