Sex-specific Differences in AAA Complexity

Sponsor
Imperial College London (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05399706
Collaborator
(none)
1,000
1
26.1
38.4

Study Details

Study Description

Brief Summary

A retrospective cohort study of computed tomography scans of AAA patients considered for repair, in order to identify sex specific differences in abdominal aortic aneurysm (AAA) metrics and the association between anatomical differences/features of complexity and adverse patient outcome.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: CTA Aorta

Detailed Description

A retrospective cohort study of computed tomography scans of AAA patients considered for repair.

The study aims to, firstly, identify sex specific differences in abdominal aortic aneurysm (AAA) metrics utilising manual and automated image processing techniques; and secondly, if numbers are sufficient, explore the association between features of AAA complexity and adverse patient outcome.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Retrospective Cohort Analysis of Sex-specific Differences in Abdominal Aortic Aneurysm Complexity and Association With Adverse Outcomes
Anticipated Study Start Date :
Jul 31, 2022
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Men

Male participants

Diagnostic Test: CTA Aorta
Computed Tomography Angiography - Aorta Whole

Women

Female Participants

Diagnostic Test: CTA Aorta
Computed Tomography Angiography - Aorta Whole

Outcome Measures

Primary Outcome Measures

  1. Sex-specific differences in thrombus burden [Pre-operative CT]

    Volumetric assessment of aortic thrombus

  2. Sex-specific differences in anatomical complexity [Pre-operative CT]

    Anatomical as assessed by current IFU (instructions for use) criteria. (Anatomy within pre-specified vessel diameter, length, tortuosity and calcification criteria for insertion of endovascular stent graft for AAA repair.)

Secondary Outcome Measures

  1. Association between anatomical differences and adverse patient outcome for patients receiving operative repair - need for transfusion, risk of vessel injury, ischaemia (bowel or limb), renal injury and re-intervention/endoleak. [30 days]

    Post-operative outcomes

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All adult patients with AAA receiving assessment +/- primary open or endovascular repair at participating centre from 1/1/2010 to 31/12/2020.

  • Must have AAA >= 5cm.

  • Must have CT imaging within 1 year of operation or definitive turn down for treatment.

Exclusion Criteria:
  • Insufficient CT imaging quality (>3mm slices) or lack of CT within 1 year of operation.

  • Insufficient clinical data to establish risk factors or clinical outcomes.

  • Ruptured aneurysm, aorto-iliac occlusive disease, isolated iliac aneurysm, penetrating aortic ulcer, dissection, juxta or supra-renal aneurysm.

  • Secondary repair/not primary treatment decision for AAA repair.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Imperial College London London United Kingdom

Sponsors and Collaborators

  • Imperial College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT05399706
Other Study ID Numbers:
  • 292985
First Posted:
Jun 1, 2022
Last Update Posted:
Jun 23, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2022