跳至主要内容
临床试验/NCT06008600
NCT06008600已完成不适用

KINO-DYSPNEA: Validation of Kinocardiography to Distinguish Dyspnea of Cardiac Origin From Others

Centre Hospitalier Universitaire de Tivoli1 个研究点 分布在 1 个国家目标入组 528 人开始时间: 2022年5月19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
入组人数
528
试验地点
1
主要终点
Evaluate the ability of the Kinocardiography technique to discriminate cardiac caused dyspnea from others.

研究概览

简要总结

Seismocardiography (SCG) measures the thoracic vibrations caused by the cardiac contraction and ejection of blood into the great vessels. Current smartphones with gyroscopes and accelerometers can measure these vibrations. Based on these components we measure and quantify the cardiac kinetic energy (kinocardiography) in order to differentiate dyspnea of cardiac origin from dyspnea of other origin. The study is conducted in an emergency service where a smartphone performs the measurement during 3 minutes. The results of the kinocardiography-based classification are then compared to the final diagnosis made by a physician. Currently, 235 patients have been included in the clinical study since May 2022. This rapid and non-invasive measurement allows the aid-to-diagnosis of heart failure without being influenced by other factors like the renal function for example that can be NT-pro BNP blood marker.

研究设计

研究类型
Observational
观察模型
Other
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 aged above 18 years old.

排除标准

  • Patients younger than 18 years old.

结局指标

主要结局

Evaluate the ability of the Kinocardiography technique to discriminate cardiac caused dyspnea from others.

时间窗: 18 months

Area under the receiver operating characteristic curve (AUROC), negative predictive value (NPV) and specificity, with two-sided 95% CIs.

次要结局

  • Open retrospective exploratory study to validate the physiological interpretation of Kinocardiography in a clinical environment.(18 months)

研究者

发起方
Centre Hospitalier Universitaire de Tivoli
申办方类型
Other
责任方
Sponsor

研究点 (1)

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