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Recruiting NCT06274697

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

No phase Interventional Lower Extremity Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Evaluation by magnetic sensor.
Who it may be relevant to
Registry conditions: Lower Extremity Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

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

Primary outcome measures

  • 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 [Time frame: On day 1]
Secondary outcome measures (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 [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 [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 [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 [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 [Time frame: On day 1]
  • Correlation of Presence of critical ischemia measured by the CapMagic prototype and the pulsed echo-Doppler recording [Time frame: On day 1]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • University Hospital Center — Montpellier

Identifiers

NCT: NCT06274697 · RECHMPL22_0391 · 2023-A01784-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗