跳至主要内容
临床试验/NCT04445012
NCT04445012Unknown不适用

Cardiovascular Acoustics and an Intelligent Stethoscope. An Observational Study to Collect Heart Sound Recordings From Patients to Understand the Acoustic Characteristics of Murmurs and Develop an Artificially Intelligent Stethoscope.

Papworth Hospital NHS Foundation Trust5 个研究点 分布在 1 个国家目标入组 1,150 人开始时间: 2019年10月24日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,150
试验地点
5
主要终点
To assess specificity of an algorithm for detecting clinically significant valve disease and congenital heart disease relative to the performance of General Practitioners

研究概览

简要总结

The aim of the project is to develop an artificial intelligence software capable of analysing heart sounds to provide early diagnosis of a variety heart diseases at an early stage. Since the invention of the stethoscope by Laennec in 1816, the basic design has not changed significantly. Our software could be coupled with existing electronic stethoscopes to create an 'intelligent' stethoscope that could be used by healthcare assistants or practice nurses to screen for sound producing heart diseases. It could also be used at home by patients who would otherwise go undiagnosed.

The study investigators at Cambridge University Engineering Department (CUED) have developed a proof-of-concept AI algorithm to detect heart murmurs. However, in order to accurately detect the specific pathology and severity underlying the murmur, more heart sound recordings (matched with the ground truth from the patient's echocardiogram) are required. Patients presenting to one of the partner hospitals requiring an echocardiogram as part of their routine care will be invited to consent to this study. Participation will entail recording of a patient's heart sounds using an electronic stethoscope as well as collection of routine clinical data and a routine clinical echocardiogram at a single routine out patient visit.

详细描述

This project will develop an AI algorithm which can be imported into a stethoscope to make it capable of automatically diagnosing any valve disease present and its severity. This will help GPs produce more accurate diagnoses, reduce costs by having fewer unnecessary referrals for echocardiogram, and produce more accurate diagnoses in countries where echocardiograms are not readily available due to their cost. Using a small sample of data as well as some which has been labelled by clinician auscultation, the team has created an award-winning AI algorithm capable of accurate detection of heart murmurs. However, in order to improve the accuracy and capability of this system more heart sound recordings from a range of diseases (matched with echocardiogram diagnosis) are required. The key to the success of this study will be to produce an AI algorithm that is more accurate than different grades of doctors at detecting the specific abnormality and severity underlying a heart murmur. This methodology will also provide a comprehensive study on acoustic characteristics of different heart sounds. So far all the acoustic characteristics of heart sounds taught to medical students are based on subjective opinion. This study will be able to objectively analyse these acoustic characteristics.

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
14 Days 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant willing and able to give informed consent for participation in study
  • Participant to undergo an echocardiogram as part of their routine assessment

排除标准

  • Informed consent is not given
  • New York Heart Association (NYHA) functional class = 4

结局指标

主要结局

To assess specificity of an algorithm for detecting clinically significant valve disease and congenital heart disease relative to the performance of General Practitioners

时间窗: Day 1

We will obtain 4, 15 second heart sound recordings from patients (at the Aortic, Pulmonary, Mitral, and Tricuspid sites) using a Littmann 3200 electronic stethoscope.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (5)

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