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临床试验/NCT03659526
NCT03659526Unknown不适用

Development, Validation and Implementation of a New Quantitative Stress Echocardiographic Test for Myocardial Ischaemia

University Hospital of Wales4 个研究点 分布在 3 个国家目标入组 390 人开始时间: 2016年1月21日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Alan G Fraser

Professor of Cardiology

University Hospital of Wales

研究点 (4)

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