Transthoracic Ultrasound Evaluation of Thoracic Aortic Aneurysms

NCT05137366 | Unknown

• 1 other identifier: RHMCAR0603
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Thoracic Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• Can ultrasound detect thoracic aortic aneurysms

  Specificity and sensitivity of ultrasound in detecting thoracic aortic aneurysms

  6 months

• Can thoracic aortic aneurysms be accurately measured using ultrasound

  Specificity and sensitivity of ultrasound in measuring thoracic aortic aneurysms

  6 months

Study Arms (2)

Known Thoracic aortic aneurysm (TAA)

* A medical confirmed TAA defined as an aneurysm measuring \>3cm in the thoracic aorta e.g. aortic arch, ascending aorta or descending thoracic aorta. * Patients may also have a AAA * Patients may have had a TEVAR and will have a residual sac * A CT scan of the aorta in the last 3 years

Diagnostic Test: Transthoracic ultrasound scan

Control group

A medically diagnosed Abdominal aortic aneurysm with a CT scan showing no TAA in the last three years. Patients who have also had their AAA repaired will also be eligible for this group.

Diagnostic Test: Transthoracic ultrasound scan

Interventions

Transthoracic ultrasound scan DIAGNOSTIC_TEST

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.

Control group; Known Thoracic aortic aneurysm (TAA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients recruited will be under the care of the Wessex vascular network at Southampton General Hospital. All patients will be identified using a key work search on CT scans from the last 5 years. This will be carried out by a member of the radiology research team at Southampton General Hospital. Participants who would be eligible for the TAA group would be identified by completing a keyword search of reports on the radiology information system (CRIS). The search will look for any CT scans with the following key words: * Thoracic aorta * Thoracic aortic aneurysm * TAAA * TEVAR * Ectatic Thoracic Aorta Participants who would be eligible for the AAA group with no known TAA would also be identified by completing a keyword search of reports on CRIS. The search will look for any CT scans with the following key words: * Abdominal aorta * Abdominal aortic aneurysm * AAA * EVAR * Ectatic abdominal Aorta

You may not qualify if:

• The Thoracic Aortic Aneurysm groups will have:
• A medical confirmed TAA defined as an aneurysm measuring \>3cm in the thoracic aorta e.g. aortic arch, ascending aorta or descending thoracic aorta.
• Patients may also have a AAA
• Patients may have had a TEVAR and will have a residual sac
• A CT scan of the aorta in the last 3 years
• The Abdominal aortic aneurysm A medically diagnosed Abdominal aortic aneurysm with a CT scan showing no TAA in the last three years. Patients who have also had their AAA repaired will also be eligible for this group.
• No diagnosed TAA or AAA
• No CT scan of aorta in last 3 years
• Under 18 years old
• Patient who are unable to consent

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Ben Patterson

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah L Davey, MSc

CONTACT

07715935328; hannah.davey@uhs.nhs.uk

Ben Patterson

CONTACT

023 8120 8801; Benjamin.Patterson@uhs.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 30, 2021
• Study Start: April 11, 2021
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)