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TransThoracic Ultrasound for Descending Aortic Aneurysms (THORUS)

3 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

60

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Carlos Pinho, PhD Student
  • Numéro de téléphone: +44 20 3312 3374
  • E-mail: cv1026@ic.ac.uk

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Royaume-Uni
    • London
      • London, London, Royaume-Uni, W2 1NY
        • Imperial College Healthcare NHS Trust - St Mary's Hospital
        • Contact:
          • Carlos Pinho, PhD Student
          • Numéro de téléphone: +44 20 3312 3374
          • E-mail: cv1026@ic.ac.uk
        • Contact:
        • Chercheur principal:
          • Carlos Pinho, PhD Student

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
CONTROLS
Patients with healthy DTA (30 patients)
CASES
Patients with DTAA or TEVAR (30 patients)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Part 1 - Feasibility - Proportion of participants with successful ultrasound measurement of the diameter of the descending thoracic aorta
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Part 1 - Feasibility - Factors limiting visualisation of the Descending Thoracic Aorta
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Imperial College London

Les enquêteurs

  • Chaise d'étude: Professor Colin Bicknell, Imperial College London

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

7 septembre 2026

Achèvement primaire (Estimé)

5 avril 2027

Achèvement de l'étude (Estimé)

3 avril 2028

Dates d'inscription aux études

Première soumission

28 juillet 2026

Première soumission répondant aux critères de contrôle qualité

3 août 2026

Première publication (Réel)

7 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 199470
  • IRAS Project ID: 365629 (Autre identifiant: NHS Health Research Authority)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Sharing IPD is not required to answer the research question.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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