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

NCT06274697 | Recruiting

• 2 other identifiers: RECHMPL22_03912023-A01784-41
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Extremity Artery Disease

Keywords

Peripheral arterial disease; Arterial Obstructive Disease; Doppler ultrasound; Magnetic sensors;

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

  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

  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

  On day 1

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

  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

  On day 1

Study Arms (1)

Magnetic sensor

EXPERIMENTAL

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

Interventions

Evaluation by magnetic sensor DEVICE

Evaluation by magnetic sensor on arm and leg

Magnetic sensor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• phymedexp: collaborator

Study Sites (1)

University Hospital Center

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Gudrun Boge, MD

CONTACT

+33467336279; g-boge@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 23, 2024
• Study Start: April 2, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

FR (1)