TransThoracic Ultrasound for Descending Aortic Aneurysms
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImperial College London
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: CONTROLS
Group B: CASES
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 1 - At the single ultrasound study visit.2
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).
Time frame
Day 1 - At the single ultrasound study visit.3
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.
Time frame
Day 1 - At the single ultrasound study visit.4
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.
Time frame
Day 1 - At the single ultrasound study visit.Secondary outcomes
1
Part 1 - Feasibility - Factors limiting visualisation of the Descending Thoracic Aorta
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.2
Part 1 - Feasibility - Duration of Ultrasound Examination
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.3
Part 1 - Feasibility - Patient Feedback Questionnaire
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.
Time frame
Day 1 - At the single ultrasound study visit.Sponsors and contacts
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Source ClinicalTrials.gov
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