Validation of a Magnetic Sensor in Arterial Flow Recording, Compared With the Reference Method, at Various Peripheral Arterial Sites

Официальное название

Validation Study of a Magnetic Sensor in Arterial Flow Recording, Compared With the Reference Method (Echodoppler), at Various Peripheral Arterial Sites

Обзор

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.

Вмешательства

• Устройство Evaluation by magnetic sensor
  Evaluation by magnetic sensor on arm and leg

Первичные конечные точки

• 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 [Срок оценки: On day 1]

Вторичные конечные точки (6)

• 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: On day 1]
• Correlation of the Systolic peak between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording [Срок оценки: 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 [Срок оценки: On day 1]
• Correlation of Presence of critical ischemia measured by the CapMagic prototype and the pulsed echo-Doppler recording [Срок оценки: On day 1]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• University Hospital Center — Montpellier

Идентификаторы

NCT: NCT06274697 · RECHMPL22_0391 · 2023-A01784-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗