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

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

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 Overview

• Status: Recruiting
• Conditions: Lower Extremity Artery Disease
• Intervention / Treatment: Device: Evaluation by magnetic sensor

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gudrun Boge, MD; Phone Number: +33467336279; Email: g-boge@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France
    • Recruiting
    • University Hospital Center
    • Contact: Gudrun BOGE, MD; Phone Number: 33 467336279; Email: g-boge@chu-montpellier.fr
    • Principal Investigator: Gudrun BOGE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Evaluation by magnetic sensor; Evaluation by magnetic sensor on arm and leg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	On day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	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.	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	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.	On day 1

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: phymedexp

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Peripheral arterial disease; Doppler ultrasound; Arterial Obstructive Disease; Magnetic sensors
• Other Study ID Numbers: RECHMPL22_0391; 2023-A01784-41 (Registry Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No