AAA - Abdominal Aortic AneurysmNCT05399706
Sex-specific Differences in AAA Complexity
An observational study of AAA - Abdominal Aortic Aneurysm, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- AAA - Abdominal Aortic Aneurysm
- What is being tested?
- CTA Aorta
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 Jul 2022to 1 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with AAA receiving assessment +/- primary open or endovascular repair.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College London
London
Colin Bicknell, +44 20 3312 6072
Anna Louise Pouncey, +44 20 3312 6072
About this study
Official title: 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.
Read the 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.
- Conditions
- AAA - Abdominal Aortic Aneurysm
- Being tested
- CTA Aorta
- 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.
CTA AortaDiagnostic test
Computed Tomography Angiography - Aorta Whole
| Study group | Role | What they receive |
|---|---|---|
| Men | Male participants Receives: Diagnostic Test: CTA Aorta | |
| Women | Female Participants Receives: Diagnostic Test: CTA Aorta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sex-specific differences in thrombus burden
Volumetric assessment of aortic thrombus
Measured: Pre-operative CT
Sex-specific differences in anatomical complexity
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.)
Measured: Pre-operative CT
Secondary outcomes (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.
Post-operative outcomes
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start31 Jul 2022 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AAA - 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
- Retrospective
- Enrolment
- 1,000 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
- NCT05399706
- Sponsor's protocol ID
- 292985
- Status last verified
- Jun 2022
- First submitted
- 24 May 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cohort Analysis of Sex-specific Differences in Abdominal Aortic Aneurysm Complexity and Association With Adverse Outcomes
- ClinicalTrials.gov ID
- NCT05399706
- Acronym / sponsor ID
- 292985
- Conditions
- AAA - Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 31 Jul 2022 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 1 Jun 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men | – | Diagnostic Test: CTA AortaMale participants |
| Women | – | Diagnostic Test: CTA AortaFemale Participants |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AAA receiving assessment +/- primary open or endovascular repair.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| CTA AortaComputed Tomography Angiography - Aorta Whole | Diagnostic test | Men, Women |
Primary outcome
Sex-specific differences in thrombus burden
Time frame: Pre-operative CT
Volumetric assessment of aortic thrombus
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.)
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Individual participant dataSharing planned: No
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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.
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 AAA - Abdominal Aortic Aneurysm, 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 3 inclusion and 4 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 23 Jun 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sex-specific differences in thrombus burden (time frame: Pre-operative CT). The study lists 2 primary outcomes in all. 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 23 Jun 2022.