Development, Validation and Implementation of a New Quantitative Stress Echocardiographic Test for Myocardial Ischaemia
试验速览
- 阶段
- 不适用
- 入组人数
- 390
- 试验地点
- 4
- 主要终点
- Diagnostic accuracy of quantitative measures of dobutamine stress echocardiography
研究概览
简要总结
Patients with chest pain on exertion need a reliable non-invasive test to identify if they have inducible myocardial ischaemia. This would reduce the use of diagnostic coronary arteriography, avoid its risks and costs, and guide clinical decisions. Conventional stress echocardiography has poor reproducibility because it relies on qualitative and subjective interpretation. Quantitative approaches based on precise and reliable measurements of myocardial velocity, strain, strain rate and global longitudinal strain have been shown to be able to accurately diagnose myocardial ischaemia. A more accurate test using myocardial velocity imaging was not implemented by ultrasound vendors although it provided an objective measurement of myocardial functional reserve on a continuous scale from normality to severe ischaemia.
The investigators propose an original approach to create a diagnostic software tool that can be used in routine clinical practice. The investigators will extract and compare quantitative data obtained through myocardial velocity imaging and speckle tracking in subjects who undergo dobutamine stress echocardiography.
The data will be analysed using advanced computational mathematics including multiple kernel learning and joint statistics applied to multivariate data across multiple dimensions (including velocity, strain and strain rate traces). This approach will be validated against quantitative coronary arteriography and fractional flow reserve. The results will be displayed as parametric images and placed into a reporting tool. The output will determine the presence and severity of myocardial ischaemia. These new tools will have the capacity for iterative learning so that the precision of the diagnostic conclusions can be continuously refined.
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
- 20 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chest pain, chest pain equivalent
排除标准
- •acute coronary syndrome with elevated troponin, severe heart valve disease, uncontrolled hypertension (resting SBP >200mmHg), cardiomyopathy, contraindication to dobutamine, pregnancy
结局指标
主要结局
Diagnostic accuracy of quantitative measures of dobutamine stress echocardiography
时间窗: 18 months
Echocardiographic measurements of segmental myocardial velocity, strain, strain rate and wall motion scoring referenced against measurements derived from coronary angiography.
次要结局
- Lowest dose of dobutamine to provoke measurable marker of inducible myocardial ischaemia(18 months)
- Diagnostic accuracy of using machine learning to interpret multiparametric and multidimensional datasets to diagnose myocardial ischaemia(18 months)
研究者
Professor Alan G Fraser
Professor of Cardiology
University Hospital of Wales
