Sex-specific Differences in AAA Complexity

Not yet recruiting

• Conditions: AAA - Abdominal Aortic Aneurysm
• Interventions: Diagnostic Test: CTA Aorta

• Registration Number: NCT05399706
• Lead Sponsor: Imperial College London

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.

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 Timeline

• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-30
• Status Verified: 2022-06
• Study First Posted: 2022-06-01
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-23
• Study Start: 2022-07-31
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Men	CTA Aorta	Male participants
Women	CTA Aorta	Female Participants

Primary Outcome Measures

Name	Time	Method
Sex-specific differences in thrombus burden	Pre-operative CT	Volumetric assessment of aortic thrombus
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

Name	Time	Method
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

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, United Kingdom