Clinical trial NCT06274697: Validation of a Magnetic Sensor in Arterial Flow Recording, Compared With the Reference Method, at Various Peripheral Arterial Sites
Official title: Validation Study of a Magnetic Sensor in Arterial Flow Recording, Compared With the Reference Method (Echodoppler), at Various Peripheral Arterial Sites
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Extremity Artery Disease
Keywords: Peripheral arterial disease
Arterial Obstructive Disease
Doppler ultrasound
Magnetic sensors;
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: phymedexp
First posted: 2024-02-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: On day 1
Secondary outcomes:
measure: 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
timeFrame: On day 1
measure: Correlation of the Pulsatility index (or Gosling Pulsatility index) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording
timeFrame: On day 1
measure: Correlation of the Systolic rise time (SRT) between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording
timeFrame: On day 1
measure: Correlation of the Systolic peak between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording
timeFrame: On day 1
measure: Correlation of the maximum acceleration of systolic rise between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording
timeFrame: On day 1
measure: Correlation of Presence of critical ischemia measured by the CapMagic prototype and the pulsed echo-Doppler recording
timeFrame: On day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital Center
Study officials:
References: