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临床试验/NCT05400421
NCT05400421Unknown不适用

Validation of Photoplethysmography Device for the Measurement of Aortic Pulse Wave Velocity Against Carotid-Femoral Values From Piezoelectric Sensors

VitalSines International Inc.0 个研究点目标入组 180 人开始时间: 2022年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
180
主要终点
Aortic Pulse Wave Velocity

研究概览

简要总结

Existing techniques available for capturing reliable aortic pulse wave velocity measurements and estimating aortic stiffness are costly and require technical expertise. The purpose of this research is to investigate an oximeter device performance as a stand-alone aortic pulse wave velocity (PWV) measurement instrument. By validating this device and its measurements against the gold-standard method of carotid-femoral readings, we aim to demonstrate that the proposed method is an comparably effective in terms of the metrics (Mean difference, standard deviation, correlation, etc.) outlined by the Artery Society Guidelines.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • History of cardiovascular disease
  • Not in sinus rhythm/arrhythmia
  • Pacemaker
  • Impalpable arterial pulse
  • Use of blood pressure medication
  • Systolic blood pressure > 140
  • Use of vasoactive medication
  • Use of cholesterol medication
  • Diabetes diagnosis
  • BMI > 30 kg/m2
  • Pregnancy

结局指标

主要结局

Aortic Pulse Wave Velocity

时间窗: 6 measurements per subject, each lasting 60 seconds

The speed at which a single pulse/heart beat propagates down the aorta.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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