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临床试验/NCT03157115
NCT03157115已完成不适用

Validation of Kinocardiography, New Technology for Cardiac Linear and Torsional Contractility Measurement, to Assess Heart Failure Patient With Low Ejection Fraction

Brugmann University Hospital2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
2
主要终点
Total heart kinetic energy

研究概览

简要总结

Measuring cardiac contractility is commonly realized with gold standard echocardiography or MRI. Portable devices to measure this contractility are not available as for rhythm and electric function assessment. The new Kinocardiography technology could provide a non invasive and portable tool to measure contractility.

This device records the electric and mechanic function of the heart simultaneously. With electrodes and adequate electronics, ECG is recorded. 6 degrees of freedom accelerometers are also included in the device to measure the micro accelerations of the body at the body surface when the device is placed on the skin. Using physics principles and adequate calibration, those accelerations allow the investigators to calculate parameters such as kinetics energies related to cardiac contractility. Kinocardiography is a non invasive and portable technology.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Control group: Left Ventricle Ejection Fraction ≥ 50 %
  • Heart failure patients: Left Ventricle Ejection Fraction < 50 %

排除标准

  • Intracardiac devices and arrhythmia at the time of assessment
  • Participates in other clinical study or trial.

结局指标

主要结局

Total heart kinetic energy

时间窗: 1 hour

Computed according to the micro accelerations of the body at the body surface. The hypothesis is that the investigators will observe a lower total heart kinetic energy for the group with impaired left ventricular ejection fraction in comparison to a paired control patient group.

次要结局

  • Ratio of torsional kinetic energy over total kinetic energy(1 hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Marielle Morissens

MD

Brugmann University Hospital

研究点 (2)

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