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临床试验/NCT03600051
NCT03600051已完成不适用

Phonokardiographie Bei Erwachsenen

CSD Labs GmbH1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CSD Labs GmbH
入组人数
90
试验地点
1
主要终点
Sensitivity for pathological heart murmur detection

研究概览

简要总结

Background: Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) via artificial intelligence algorithms could be a useful tool to assist healthcare providers in identifying pathological heart murmurs and may avoid unnecessary referrals to medical specialists.

Objective: Assess the quality of the artificial intelligence (AI) algorithm that autonomously detects and classifies heart murmurs as either pathologic (AHA class I) or as no- or innocent (AHA class III).

Hypothesis: The algorithm used in this study is able to analyze and identify pathologic heart murmurs (AHA class I) in an adult population with valve defects with a similar sensitivity compared to medical specialist.

Methods: Each patient is auscultated and diagnosed independently by a medical specialist by means of standard auscultation. Auscultation findings are verified via gold-standard echocardiogram diagnosis. For each patient, a phonocardiogram (PCG) - a digital recording of the heart sounds - is acquired. The recordings are later analyzed using the AI algorithm. The algorithm results are compared to the findings of the medical professionals as well as to the echocardiogram findings.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Adults with a heart defect verified by echocardiography

排除标准

  • 未提供

结局指标

主要结局

Sensitivity for pathological heart murmur detection

时间窗: 2 months

Ability to detect a pathological heart murmur in digital heart sound recordings obtained from an elderly population with heart valve disease.

次要结局

未报告次要终点

研究者

发起方
CSD Labs GmbH
申办方类型
Other
责任方
Sponsor

研究点 (1)

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