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临床试验/NCT04647448
NCT04647448撤回不适用

Multisensor Array for the Localisation of Coronary Artery Stenosis

Barts & The London NHS Trust0 个研究点目标入组 120 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
120
主要终点
Diagnostic accuracy

研究概览

简要总结

This is a proof of concept study involving a novel medical device, developed to investigate the potential for detecting and localising coronary artery stenosis. A prototype device will be used in the proposed clinical investigation. It is a stick-on patch containing sensors which measure the sound produced at and the movement of, the chest surface by flowing blood as it accelerates through the stenosis and becomes disturbed as it emerges downstream, allowing the blockage to be detected and localised non-invasively.

The proposed clinical investigation will involve a small number of patients and healthy volunteers. The patients will be drawn from those attending The BartsHeart Centre for suspected or diagnosed coronary artery disease and all clinical measurements will take place at Barts Health Trust. The patch to be used in the proposed clinical investigation incorporates commercially available sensors and will be tested by recording acoustic signatures in healthy volunteers, then in patients undergoing coronary CT angiography at Barts. Signals will be analysed initially by measuring their acoustic energy at various frequencies and in later iterations, by a machine-learning algorithm. Results will be validated against the CT angiography gold standard.

详细描述

This project is a trial of a novel device, in the form of a stick-on patch containing miniature accelerometers and microphones, designed to detect sounds produced by disturbed blood flow in stenosed coronary arteries. Initially, acoustic data will be collected from a small group of healthy volunteers to confirm proof of concept. Recordings from the patch will then be made on up to 100 patients who, having presented with chest pain to the Barts Heart Clinic, are undergoing simultaneous CTa investigations to determine the presence or absence of occlusive CAD.

The purpose of the study is to determine if the nature of the signals recorded by the patch makes it possible to distinguish those patients who have identifiable CAD, as detected by CTa (the reference method) from those in whom no occlusive lesions can be seen in the CTa images. The measurements on patients will be preceded by a trial on 20 healthy volunteers to establish base line readings and to ensure the reliability of the patch and the associated data acquisition system, in the field.

Coronary artery disease (CAD) is the leading cause of death worldwide. In Europe alone in 2014 the resulting cost of health care, and lost production was around €100 billion per year. Existing diagnostic methods apart from ECG require skilled operators and expensive equipment.

Recent advances in cCTA make it possible to detect and localise occlusive lesions with high accuracy and precision, whilst minimising the use of contrast media, albeit at the cost of some exposure to ionising radiation. Of equal or greater concern is the fact that approximately 2/3 of symptomatic patients are found, on investigation, to be occlusion-free, representing a great waste of resources and thus a loss of productivity for the healthcare system and the patients themselves, to say nothing of their distress on facing a false positive diagnosis and the risks associated with contrast injection and exposure to unnecessary ionising radiation.

The non-invasive system proposed here would be applied to symptomatic patients with stable chest pain attending a cardiac outpatient clinic with the intention of screening out the 2/3 mentioned above, resulting in large cost and time savings.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Diagnostic accuracy

时间窗: Through study completion, 1 year

Diagnostic accuracy of the device (stick-on patch) for indicating the presence or absence of one or more coronary arterial stenoses as indicated by the reference method (CT angiography results)

次要结局

  • Stenosis severity(Through study completion, 1 year)
  • Number of stenoses(Through study completion, 1 year)
  • Stenosis position(Through study completion, 1 year)

研究者

申办方类型
Other
责任方
Sponsor

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