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

University Hospital, Montpellier70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Lower Extremity Artery Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

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

Time frame: On day 1

Secondary Outcomes

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, in adult patients with or without LEAD 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

Time frame: 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

IP=P/M where P=maximum amplitude of the trace (from highest positive value, i.e. peak systolic, to lowest value) and M=average circulatory velocity, averaged over the entire cardiac cycle. Calculated from the Doppler or CapMagic curves.

Time frame: 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

Systolic rise time (SRT), (ms) : the time between the foot and the peak of the pulse wave. Calculated from the Doppler or CapMagic curves.

Time frame: On day 1

Correlation of the Systolic peak between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording

Systolic peak, Measured in cm/s or mV: Peak height in systole. Calculated from the Doppler or CapMagic curves.

Time frame: 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

The maximum acceleration of systolic rise (cm/s2) calculated from the Doppler or CapMagic curves.

Time frame: On day 1

Correlation of Presence of critical ischemia measured by the CapMagic prototype and the pulsed echo-Doppler recording

critical ischemia is defined by systolic pressure at toe \< 30 mmHg or ankle \< 50mmHg, or diagnosis of critical ischemia retained by the team in the impossibility of obtaining pressure measurements

Time frame: On day 1

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts