Transthoracic Ultrasound Evaluation of Thoracic Aortic Aneurysms

NCT05137366 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-04-13

No results posted yet for this study

Summary

The Diagnosis of a thoracic Aortic Aneruysms usually made when imaging an abdominal aortic aneurysm which has reached threshold or as an incidental finding during a chest scan by computed tomography (CT) or magnetic resonance imaging (MRI). However, these imaging modalities are expensive, involve radiation exposure and can cause anaphylaxis and other allergic reaction from the contract agents used. In addition CT scans are contraindicated for those who have: allergic reactions to the contrast, radioactive iodine treatment for thyroid disease, metformin use, and chronic or acutely worsening renal disease.

Ultrasound is a non-invasive imaging modality that is cheaper than the methods currently used for TAA detection and surveillance. Echocardiography is limited in assessing the TAA as it is not sensitive to image beyond the proximal ascending aorta which is why it is currently not used for screening or surveillance.

A pilot study found that ultrasound has the potential to be used as a diagnostic modality for thoracic aortic aneurysms and may have a role in surveillance in patients for whom CT scanning is contraindicated. They found that the sensitivity and specificity of detecting TAA was 100% and 70% for a threshold of 35 mm, and 84% and 90% for a threshold of 40 mm. However, further validation of this methodology is required for it to be considered as a method of diagnosis and surveillance for this patient group. This study was only carried out by one experienced sonographer so it important to repeat this study to see if other sonographers are able to obtain the necessary views.

The main purpose of this study is to validate the protocol used by pilot study to assess whether thoracic aortic aneurysms can be detected and measured accurately using ultrasound.

There are two main objectives of this study:

1. Can ultrasound be used to detect thoracic aortic aneurysms?
2. Can ultrasound be used to accurately measure thoracic aortic aneurysms?

If the results of this study show that ultrasound has high sensitivity and specificity for detecting thoracic aortic aneurysms, it could lead to a thoracic aorta screening programme.

Conditions

  • Thoracic Aortic Aneurysm

Interventions

DIAGNOSTIC_TEST

Transthoracic ultrasound scan

An ultrasound scan of the thoracic aorta will be performed using an ultrasound machine with 2 MHz phased array transducer. The patient will lay supine on an ultrasound scan couch.The measurements will be taken in B-mode but colour Doppler imaging may be used to identify the thoracic aorta if it is obscured by artefacts. The measurement will be taken inner wall to inner wall and several images will be taken to check reliability. Three different acoustic windows will be used to image the thoracic aorta: 1. Suprasternal window 2. Parasternal long axis window 3. Apical two chamber views Ultrasound assessment will be considered satisfactory when at least two of the three regions of the descending thoracic aorta were visualised, partially satisfactory when a single view was obtained and inconclusive when none of the three windows could be obtained.

Sponsors & Collaborators

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Ben Patterson · University Hospital Southampton NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-11
Primary Completion
2023-07-31
Completion
2023-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05137366 on ClinicalTrials.gov