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

Lower Extremity Artery Disease Clinical Trial

— COMADO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06274697
• Other study ID #: RECHMPL22_0391
• Secondary ID: 2023-A01784-41
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Montpellier
• Contact: Gudrun Boge, MD
• Phone: +33467336279
• Email: g-boge[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Extremity Artery Disease

Intervention

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

Locations

Country	Name	City	State
France	University Hospital Center	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	phymedexp

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Correlation of the Type of flow according to Saint-Bonnet classification between the signal recording obtained by the CapMagic prototype and the pulsed echo-Doppler recording	The Saint Bonnet classification grades the progressive deterioration of flows. It is used as described in Mahé G, Boulon C, Desormais I, Lacroix P, Bressollette L, Guilmot JL, Le Hello C, Sevestre MA, Pernod G, Constans J, Boissier C, Bura-Rivière A. Statement for Doppler waveforms analysis. Vasa. 2017 Aug;46(5):337-345. doi: 10.1024/0301-1526/a000638. Epub 2017 May 19. PMID: 28521662.	On day 1
Secondary	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