Imperial College Healthcare NHS Trust - St Mary's Hospital
London, W2 1NY, United Kingdom
Location contact
Carlos Pinho, PhD Student
CONTACT
Carlos Pinho, PhD Student
PRINCIPAL_INVESTIGATOR
Cheuk Fund Wong
CONTACT
NCT Number: NCT07752654
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 opening soon.
Get Notified18 year and older
All sexes
Observational
London, W2 1NY, United Kingdom
Carlos Pinho, PhD Student
CONTACT
Carlos Pinho, PhD Student
PRINCIPAL_INVESTIGATOR
Cheuk Fund Wong
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Day 1 - At the single ultrasound study visit.
Calculate mean differences and limits of agreement between TUS and CT. Achieve high sensitivity and specificity.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Carlos Pinho, PhD Student
CONTACT
Cheuk Fund Wong
CONTACT
Imperial College London
Other
Feasibility, Accuracy and Reproducibility of Ultrasound in Aneurysms of the Descending Thoracic Aorta
Acronym: THORUS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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