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NCT Number: NCT06274697

Validation of a Magnetic Sensor in Arterial Flow Recording, Compared With the Reference Method, 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.

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Key information

Conditions

Lower Extremity Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Center

Montpellier, France

Location status: Recruiting

Location contact

Gudrun BOGE

PRINCIPAL_INVESTIGATOR

Gudrun BOGE, MD

CONTACT

[email protected]

467336279 ext. 33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation by magnetic sensor

Device

Evaluation by magnetic sensor on arm and leg

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

    Time frame: On day 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, 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

Secondary outcomes

  1. 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

    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

  2. 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

    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.

  3. 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

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

  4. 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

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

  5. 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

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

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

    Time frame: On day 1

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Gudrun Boge, MD

CONTACT

[email protected]

+33467336279

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • phymedexp

Registry information

Official study title

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

Acronym: COMADO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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