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TransThoracic Ultrasound for Descending Aortic Aneurysms (THORUS)

3 augustus 2026 bijgewerkt door: Imperial College London

Feasibility, Accuracy and Reproducibility of Ultrasound in Aneurysms of the Descending Thoracic Aorta

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

Aneurysms of the aortic artery are a significant public health issue. The number of newly diagnosed aneurysms of the thoracic aorta is on the rise, and aneurysm rupture is a catastrophic event associated with high mortality rates. The most proximal sections of the aorta (ascending and the aortic arch) are routinely scanned by echocardiography practitioners. The abdominal aorta is also easily visualised on transabdominal ultrasound, and there is a screening programme in the UK that is highly cost-effective and reduced the aneurysm-related number of deaths. However, the portion of the aorta in the chest (descending thoracic aorta) is not routinely assessed by ultrasound practitioners.

The diagnosis of descending thoracic aneurysms relies mostly on imaging techniques that use ionising radiation. In addition, these techniques are expensive and may not be widely available in some regions. In contrast, ultrasound is a non-invasive technique that allows visualisation of most parts of the body. Ultrasound machine suppliers have invested in better systems and transducers over the years and visualisation of the descending thoracic aorta may now be possible.

The main aims of this study are to assess the feasibility (Part 1), accuracy (Part 2) and reproducibility (Part 3) ultrasound in the diagnosis and monitoring of descending thoracic aortic aneurysms. Participants will be recruited from the vascular lab and outpatient clinics, and diameters of the descending thoracic aorta will be measured with non-invasive ultrasound. Data obtained from study measurements will be compared with computed tomography scans that patients had as part of their standard of care.

If the feasibility, accuracy and reproducibility of Ultrasound are clearly demonstrated, routine ultrasound scans of the descending thoracic aorta may be suggested.

Studietype

Observationeel

Inschrijving (Geschat)

60

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Carlos Pinho, PhD Student
  • Telefoonnummer: +44 20 3312 3374
  • E-mail: cv1026@ic.ac.uk

Studie Contact Back-up

Studie Locaties

  • Verenigd Koninkrijk
    • London
      • London, London, Verenigd Koninkrijk, W2 1NY
        • Imperial College Healthcare NHS Trust - St Mary's Hospital
        • Contact:
          • Carlos Pinho, PhD Student
          • Telefoonnummer: +44 20 3312 3374
          • E-mail: cv1026@ic.ac.uk
        • Contact:
        • Hoofdonderzoeker:
          • Carlos Pinho, PhD Student

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Although rare, ultrasound contraindications as described in the scanning protocol are also exclusion criteria.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
CONTROLS
Patients with healthy DTA (30 patients)
CASES
Patients with DTAA or TEVAR (30 patients)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Part 1 - Feasibility - Proportion of participants with successful ultrasound measurement of the diameter of the descending thoracic aorta
Tijdsspanne: Day 1 - At the single ultrasound study visit.
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
Tijdsspanne: Day 1 - At the single ultrasound study visit.
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
Tijdsspanne: Day 1 - At the single ultrasound study visit.

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
Tijdsspanne: Day 1 - At the single ultrasound study visit.
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
Tijdsspanne: Day 1 - At the single ultrasound study visit.
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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Part 1 - Feasibility - Factors limiting visualisation of the Descending Thoracic Aorta
Tijdsspanne: Day 1 - At the single ultrasound study visit.
Number and percentages of participants in whom limiting factors such as body habitus or rib shadowing are reported after the ultrasound test. The units of measure are the number of participants with raised BMI (kg/m^2) and acoustic shadowing due to bone density.
Day 1 - At the single ultrasound study visit.
Part 1 - Feasibility - Duration of Ultrasound Examination
Tijdsspanne: Day 1 - At the single ultrasound study visit.
Total time needed to complete the ultrasound scan of the descending thoracic aorta. The unit of measure is minutes.
Day 1 - At the single ultrasound study visit.
Part 1 - Feasibility - Patient Feedback Questionnaire
Tijdsspanne: Day 1 - At the single ultrasound study visit.
Scores are obtained from the patient feedback questionnaire that was created specifically for this study and consists of 5 questions relating to comfort, tolerability and overall experience of the ultrasound scan. The unit of measure is a score ranging from 1-Strongly Disagree to 5-Strongly Agree. Higher scores mean better patient satisfaction.
Day 1 - At the single ultrasound study visit.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Imperial College London

Onderzoekers

  • Studie stoel: Professor Colin Bicknell, Imperial College London

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

7 september 2026

Primaire voltooiing (Geschat)

5 april 2027

Studie voltooiing (Geschat)

3 april 2028

Studieregistratiedata

Eerst ingediend

28 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 augustus 2026

Eerst geplaatst (Werkelijk)

7 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

3 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 199470
  • IRAS Project ID: 365629 (Andere identificatie: NHS Health Research Authority)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Sharing IPD is not required to answer the research question.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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