Mazankowski - Echo Go Discovery Protocol Retrospective LVEF/GLS Comparison
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms with and without the application of contrast agents.
研究概览
简要总结
This study aims to compare conventionally acquired Left Ventricle Ejection Fraction (LVEF) and Global Longitudinal Strain (GLS) data to Artificial Intelligence (AI) driven automated processing of 2 dimensional contrast and 2 dimensional non-contrast resting transthoracic echocardiograms for application in the assessment of patients undergoing chemotherapy with cardiotoxic drugs. This is a single-centre retrospective study which utilizes echocardiographic DICOM image and meta-data datasets received from a Canadian site. Data processed using the AI driven automated processing will be compared to conventionally acquired LVEF and GLS measurements and results will be analysed to determine accuracy and precision.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Normal EF and no regional wall motion abnormalities prior to starting chemotherapy treatment.
- •Follow-up EF measurements available for at least 1 year during the treatment period.
- •Follow-up EF measurements for at least 1 year during the treatment period.
排除标准
- •Age < 18 years
- •Inadequate image quality (as determined by the Ultromics Operators Quality Control process)
结局指标
主要结局
Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms with and without the application of contrast agents.
时间窗: Follow up (up to 1 year)
Measurements will be assessed using bias and 95% confidence internals on bias. Regression coefficients, comparative statistics and equivalence testing might also be employed as a comparison measure for this objective.
Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms against conventional measurement acquisition.
时间窗: Follow up (up to 1 year)
Measurements shall be compared using bias and 95% confidence intervals on bias. Regression coefficients and comparative statistics will be employed for this objective.
次要结局
未报告次要终点