NCT07752654

Brief Summary

The goal of this observational study is to assess the applicability of non-invasive ultrasound in aneurysms of the descending thoracic aorta. The main question it aims to answer is: What is the feasibility of Ultrasound to visualise the Descending Thoracic Aorta, and can this imaging modality accurately measure the maximum size of aneurysms and residual sacs with acceptable reproducibility? Participants are having their diagnosis confirmed or excluded by conventional imaging techniques (CT scans). Participants receive exactly the same standard of care regardless of their participation. The study offers an additional ultrasound scan, and the results will be compared with previous imaging.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
19mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 7, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2027

12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2028

Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

July 28, 2026

Last Update Submit

August 3, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Part 1 - Feasibility - Proportion of participants with successful ultrasound measurement of the diameter of the descending thoracic aorta

    Number and percentage of participants in whom the descending thoracic aortic diameter can be obtained by transthoracic ultrasound. The units of Measure are total number and percentages.

    Day 1 - At the single ultrasound study visit.

  • Part 1 - Feasibility - Length of the descending thoracic aorta by Ultrasound

    Total length of the descending thoracic aorta from the aortic isthmus to the coeliac axis. The unit of Measure is Centimetres (cms).

    Day 1 - At the single ultrasound study visit.

  • Part 1 - Feasibility - Ultrasound Quality Score

    Number of ultrasound windows that allow visualisation of the descending thoracic aorta (0 to 3 windows) and allocation of a quality score. The Unit of Measure is a score created for this study (0-Windows: No views; 1 window: Poor; 2 windows: Moderate; 3 windows: Good). Higher scores mean better image quality.

    Day 1 - At the single ultrasound study visit.

  • Part 2 - Accuracy - Comparision between Transthoracic Ultrasound and CT

    Calculate mean differences and limits of agreement between TUS and CT. Achieve high sensitivity and specificity.

    Day 1 - At the single ultrasound study visit.

  • Part 3 - Reproducibility - Intraclass correlation coefficient

    Calculate inter- and intra-operator variability by intraclass correlation coefficient (ICC). The study aims to achieve good or excellent reliability.

    Day 1 - At the single ultrasound study visit.

Secondary Outcomes (3)

  • Part 1 - Feasibility - Factors limiting visualisation of the Descending Thoracic Aorta

    Day 1 - At the single ultrasound study visit.

  • Part 1 - Feasibility - Duration of Ultrasound Examination

    Day 1 - At the single ultrasound study visit.

  • Part 1 - Feasibility - Patient Feedback Questionnaire

    Day 1 - At the single ultrasound study visit.

Study Arms (2)

CONTROLS

Patients with healthy DTA (30 patients)

CASES

Patients with DTAA or TEVAR (30 patients)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All Participants will receive a single Ultrasound scan as part of this study. All Patients had at least one CT scan of the thoracic aorta prior to the study as part of their standard of care. No additional radiation or invasive imaging techniques will be used in the Thorus study. The data obtained from the CT will be analysed by an independent reviewer and compared with Ultrasound measurements. Participants will be recruited prospectively from a single NHS Trust in London - Imperial College Healthcare NHS Trust.

You may qualify if:

  • Patients with diagnosed AAA or other vascular condition attending the vascular scanning department for routine ultrasound and confirmed healthy DTA (Control group).
  • Patients with known DTAA (including Type B dissection) or patients who had TEVAR previously (Case group).
  • Patients who have had CT as part of their standard of care.
  • Patients able to tolerate the scan (Lying in supine position).
  • Adults aged 18 or over.
  • Willing to provide consent.

You may not qualify if:

  • Patient under 18 years of age.
  • Previous thoracic surgery or body deformity (severe kyphosis, scoliosis, pleural effusion or chest wall trauma).
  • Patients without previous imaging of the thoracic aorta.
  • Life expectancy \<2 years.
  • Pregnant Women.
  • Patients unwilling to provide consent or unable to comply with study requirements.
  • Patients too frail to travel to routine outpatient appointments.
  • Inability to attend the appointment due to time constraints or other commitments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust - St Mary's Hospital

London, London, W2 1NY, United Kingdom

Location

Study Officials

  • Professor Colin Bicknell

    Imperial College London

    STUDY CHAIR

Central Study Contacts

Carlos Pinho, PhD Student

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2026

First Posted

August 7, 2026

Study Start (Estimated)

September 7, 2026

Primary Completion (Estimated)

April 5, 2027

Study Completion (Estimated)

April 3, 2028

Last Updated

August 7, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Sharing IPD is not required to answer the research question.

Locations