Transthoracic Ultrasound Evaluation of Thoracic Aortic Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Can ultrasound detect thoracic aortic aneurysms
研究概览
简要总结
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:
- Can ultrasound be used to detect thoracic aortic aneurysms?
- 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.
详细描述
It is important to state that patients involved in this study will not have any changes made to their routine care as a result of this study. All patients recruited would have had a recent CT scan which will be used for the comparison and will not be exposed to any additional radiation as part of the study. The CT scan used will be from the last 3 years so no new diagnoses are expected as a result of the study.
Patients There will be two different groups recruited for this study; Group 1- patients with known thoracic aortic aneurysm (TAA) and Group 2- patients with known abdominal aortic aneurysm (AAA) but no thoracic aortic aneurysm. The known TAA group will be obtained from those who are currently having CT surveillance for either a known TAA or TEVAR (Thoracic Endovascular Repair). The known AAA but no TAA will be obtained from patients who are either under for CT surveillance AAA or EVAR (Endovascular Aneurysm Repair). All patients recruited for this study will be under CT surveillance at Southampton General Hospital or Queen Alexandra hospital and would have had a CT scan within the last 3 years at University Hospital Southampton so no new findings would be expected to come from the study. In addition, the CT scan used will be part of their routine care and there will be no change to their routine care or surveillance as a result of this study.
Both Males and Female participants will be recruited for the study and there will also be a minimum age of 18 as gender will not influence the results of the study.
Participant Recruitment Any patients eligible for the study will be contacted to see if they are interested in taking part and given a participant information sheet. The participant information sheet (PIS) will entail the full details of the study and what it will involve for the patient.
If a patient is interested in participating in the study, a telephone call appointment will be arranged between a member of the research team and the patient. This phone call will involve going through the PIS, answering any questions, and obtaining verbal informed consent. During this appointment, an ultrasound scan appointment will also be arranged.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For both the Thoracic Aortic Aneurysm (TAA) group and control group, there are no exclusion criteria for gender, ethnicity or socioeconomic status. However, all patients must have a minimum age of 18 years. Patients must have a diagnosis of a Thoracic Aortic Aneurysm or/and Abdominal aortic aneurysm (AAA)
- •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.
排除标准
- •• No diagnosed TAA or AAA
- •No CT scan of aorta in last 3 years
- •Under 18 years old
- •Patient who are unable to consent
结局指标
主要结局
Can ultrasound detect thoracic aortic aneurysms
时间窗: 6 months
Specificity and sensitivity of ultrasound in detecting thoracic aortic aneurysms
Can thoracic aortic aneurysms be accurately measured using ultrasound
时间窗: 6 months
Specificity and sensitivity of ultrasound in measuring thoracic aortic aneurysms
次要结局
未报告次要终点