Validation Study of a Magnetic Sensor in Arterial Flow Recording, Compared With the Reference Method (Echodoppler), at Various Peripheral Arterial Sites
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Correlation of the two curve amplitudes (y) versus time (x) between the signal recording obtained by the CapMagic prototype on the radial artery and the pulsed echo-Doppler recording on the radial artery
研究概览
简要总结
The measurement of magnetic fields emitted by cardiac activity has already been studied in magneto-cardiography. To date, however, this technology has never been evaluated in the peripheral circulation.
The magnetic susceptibility of iron in the circulating blood and the ionic currents in the blood stream generate a very weak induced magnetic current, which can be detected by the micro-sensor of the prototype investigators wish to study.
Proving the validity of this prototype would make it a new diagnostic and even prognostic tool, non-invasive, less costly and more accessible than Doppler for screening peripheral arterial disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized in the Heart-Lung Unit of the Montpellier University Hospital, for any reason whatsoever
- •Patient with lower extremity artery disease (LEAD) (stage 1 to 4 according to Leriche and Fontaine) or not (absence of LEAD)
- •Age ≥ 18 years
排除标准
- •Patient with a metal implant in the vicinity of the device's area of use
- •Patient requiring additional hygiene precautions
- •Subject not affiliated to a social security scheme or not benefiting from such a scheme.
- •Pregnant or breast-feeding woman, patient unable to give consent, protected adult, vulnerable persons
- •Subject deprived of liberty by judicial or administrative decision
- •Patient refusing to give consent
研究组 & 干预措施
Magnetic sensor
The CapMagic device is a small magnetic sensor, whose technology is derived from magnetocardiography, with a very weak field identical to that of a refrigerator magnet, which is placed on the foot or toe to record curves reflecting the state of the arterial network. It does not require direct skin contact.
干预措施: Evaluation by magnetic sensor (Device)
结局指标
主要结局
Correlation of the two curve amplitudes (y) versus time (x) between the signal recording obtained by the CapMagic prototype on the radial artery and the pulsed echo-Doppler recording on the radial artery
时间窗: On day 1
Correlation of the two curve amplitudes (y) versus time (x) between the signal recording obtained by the CapMagic prototype on the radial artery and the pulsed echo-Doppler recording on the radial artery, in adult patients with or without AOMI in hospital. The result is expressed by a Spearman correlation coefficient ranging from -1 to 1, with 0 corresponding to no correlation and 1 corresponding to a perfect positive correlation
次要结局
- Correlations of the two curve amplitudes (y) versus time (x) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording, measured on the plantar artery on one side and on the pulpal artery on the other(On day 1)
- Correlation of the Pulsatility index (or Gosling Pulsatility index) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording(On day 1)
- Correlation of the Systolic rise time (SRT) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording(On day 1)
- Correlation of the Systolic peak between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording(On day 1)
- Correlation of the maximum acceleration of systolic rise between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording(On day 1)
- Correlation of Presence of critical ischemia measured by the CapMagic prototype and the pulsed echo-Doppler recording(On day 1)