Sex-specific Differences in AAA Complexity

June 22, 2022 updated by: Imperial College London

Retrospective Cohort Analysis of Sex-specific Differences in Abdominal Aortic Aneurysm Complexity and Association With Adverse Outcomes

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Imperial College London
        • Contact:
          • Colin Bicknell
          • Phone Number: +44 20 3312 6072
        • Contact:
          • Anna Louise Pouncey
          • Phone Number: +44 20 3312 6072

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with AAA receiving assessment +/- primary open or endovascular repair.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sex-specific differences in thrombus burden
Time Frame: Pre-operative CT
Volumetric assessment of aortic thrombus
Pre-operative CT
Sex-specific differences in anatomical complexity
Time Frame: 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.)
Pre-operative CT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 30 days
Post-operative outcomes
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 31, 2022

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

May 24, 2022

First Submitted That Met QC Criteria

May 30, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 292985

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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