Echocardiographic Detection of Cardiotoxicity Using the Ventripoint (VMS) 3D AI Echocardiography System Versus Conventional Echo Analyses and Cardiac MRI in Patients Receiving Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Comparison of LVEF measured by V-echo and L-echo in comparison to CMR at baseline imaging
研究概览
简要总结
To investigate the clinical utility of both 3D and 2D artificial intelligence reconstruction echocardiography (V-echo and L-echo) assessment against conventional echocardiography and clinical cardiovascular magnetic resonance (CMR) imaging for the characterisation of cardiac function and detection of cardiotoxicity in patients receiving chemotherapy.
Diagnostic accuracy of V-echo and L-echo for quantification of cardiac chamber sizes and systolic function (left ventricular ejection fraction (LVEF) and strain analyses) versus conventional echocardiography (C-echo) and CMR; workflow measures including imaging temporal measures of image acquisition, registration and analysis versus conventional approaches; survey of markers of acceptability by patients and sonographers; cost effectiveness analysis of V-echo and L-echo versus conventional echocardiography; assessment of the relationship between 3D strain parameters derived from V-echo data, 2D strain parameters derived from L-echo and correlation with conventional markers of cardiac function, namely LVEF and global longitudinal strain.
详细描述
Breast cancer is the second most prevalent cancer worldwide, causing 11.6% of global cancer diagnoses.1 It is a common and significant cause of morbidity and mortality. Despite improving survival, 11,500 women and 85 men die from breast cancer in the United Kingdom annually.2 Chemotherapy with trastuzumab is an important part of treatment but carries a potential risk of chemotherapy-induced cardiotoxicity, observed as clinical or subclinical left ventricular dysfunction.3 The implications of such cardiotoxicity are important, to both the chemotherapy regime as well as to cardiac function. Thus, it is a potential disruptor to the chemotherapy itself, and while it may in some cases produce subclinical cardiac dysfunction, in others it may result in overt heart failure with its associated signs and symptoms.
The early and accurate diagnosis of cardiotoxicity is therefore vital for preventing significant reduction in left ventricular (LV) function, and to afford institution of cardioprotective medications that may both improve cardiac function and even allow a return to chemotherapy with continued heart failure medications on board. Conversely, late detection may result in more serious heart failure, and a lower ability to continue trastuzumab chemotherapy.
In line with current international guidance, serial transthoracic echocardiography (TTE) is the first line investigation of choice for the surveillance of cardiac function.4,5 This requires standard 2-D echocardiography with as high image quality as possible, to accurately quantify left ventricular size and function. In the United Kingdom, minimum datasets for standard echocardiography are outlined by the British Society for Echocardiography (BSE) guidelines, these include standard views and measurements to ideally be obtained or calculated during a scan. For patients having undergone potentially cardiotoxic chemotherapy the BSE and British Cardio-Oncology Society (BCOS) advise measures as outlined below in addition to the minimum echocardiography data set: 5
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In all cases, volumetric analysis of left ventricular cavity size and function
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Simpson's biplane method. This is a conventional measure that using 2D imaging, from two orthogonal planes, to estimate left ventricular volumes.
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Ideally, and subject to image quality, volumetric quantification of cardiac function should be made using 3D LV size and ejection fraction analysis from a 3D dataset acquired using a 3D transducer. This overcomes the mathematical assumptions central to (a) above, although, temporal resolution is sacrificed at the expense of 3D image acquisition.
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2-D global longitudinal strain (GLS) analysis. This is highly dependent on image quality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Aged 18 years or older
- •Received potentially cardiotoxic chemotherapy
- •Participant requires echocardiography surveillance as standard current practice
排除标准
- •Below the age of 18 years old
- •Inability to give informed consent
- •Implanted cardiac devices
- •Not having received cardiotoxic chemotherapy. Ineligible patients and patients not wishing to take part will be excluded, the reasons for this will be recorded and baseline CONSORT demographics noted including age, gender, ethnicity.
研究组 & 干预措施
Clinical utility of V-echo and L-echo
Evaluate the clinical utility of V-echo and L-echo against standard practice in patients who have received potentially cardiotoxic chemotherapy.
干预措施: V-echo (Other)
Clinical utility of V-echo and L-echo
Evaluate the clinical utility of V-echo and L-echo against standard practice in patients who have received potentially cardiotoxic chemotherapy.
干预措施: L-echo (Other)
结局指标
主要结局
Comparison of LVEF measured by V-echo and L-echo in comparison to CMR at baseline imaging
时间窗: 2 years
次要结局
- Comparison of V-echo and L-echo versus CMR volumetric quantification(2 years)
- Comparison of V-echo and L-echo versus C-echo volumetric quantification(2 years)
- Patient and staff acceptability surveys(2 years)