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TransThoracic Ultrasound for Descending Aortic Aneurysms (THORUS)

2026年8月3日 更新者：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.

調査の概要

状態

まだ募集していません

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

60

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Carlos Pinho, PhD Student
  • 電話番号：+44 20 3312 3374
  • メール：cv1026@ic.ac.uk

研究連絡先のバックアップ

研究場所

  • イギリス
    • London
      • London、London、イギリス、W2 1NY
        • Imperial College Healthcare NHS Trust - St Mary's Hospital
        • コンタクト：
          • Carlos Pinho, PhD Student
          • 電話番号：+44 20 3312 3374
          • メール：cv1026@ic.ac.uk
        • コンタクト：
        • 主任研究者：
          • Carlos Pinho, PhD Student

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
CONTROLS
Patients with healthy DTA (30 patients)
CASES
Patients with DTAA or TEVAR (30 patients)

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Part 1 - Feasibility - Proportion of participants with successful ultrasound measurement of the diameter of the descending thoracic aorta
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Part 1 - Feasibility - Factors limiting visualisation of the Descending Thoracic Aorta
時間枠：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
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Imperial College London

捜査官

  • スタディチェア：Professor Colin Bicknell、Imperial College London

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月7日

一次修了 (推定)

2027年4月5日

研究の完了 (推定)

2028年4月3日

試験登録日

最初に提出

2026年7月28日

QC基準を満たした最初の提出物

2026年8月3日

最初の投稿 (実際)

2026年8月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月7日

QC基準を満たした最後の更新が送信されました

2026年8月3日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 199470
  • IRAS Project ID: 365629 (その他の識別子：NHS Health Research Authority)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Sharing IPD is not required to answer the research question.

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