MR-compatible 12-lead ECG recording system
DeviceContinuous 12-lead ECG recordings will be measured during cardiac MRI scans, using the MiRTLE Medical system. In addition, a reference clean ECGs will be measured outside the MRI environment.
NCT Number: NCT07456644
This study aims to improve the quality of 12-lead ECG recordings taken during a cardiac MRI scan. The ECG is important for monitoring the heart's rhythm and for properly timing MRI image acquisition.
During MRI scans, the magnetic field can distort ECG signals, making it more difficult to accurately monitor the heart. By improving ECG signal quality during MRI, we hope to enhance patient safety, improve monitoring for patients with implanted heart devices, and support MRI-guided procedures.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
ECG signals acquired within the MRI environment are prone to distortion due to the influence of the static magnetic field (SMF), time-varying gradients (i.e. gradient-induced voltages (GIVs)), and radio frequency (RF) pulses. In particular, the MHD effects, predominantly resulting from the pulsatile aortic electrically conductive blood flow within the magnetic field, produce ECG distortions that potentially obscure important ECG-features, like acute changes in the ST-segment and T-wave.
These distortions not only hinder accurate ECG interpretation but may also compromise image quality due to erroneous cardiac triggering. Furthermore, time-varying magnetic field gradients induce gradient-induced voltages (GIVs) during active scanning sequences, producing characteristic ECG artifacts that further challenge signal reliability within the MRI environment.
Recently, a first CE-marked, commercially available MRI-compatible 12-lead ECG system (MiRTLE Medical, North Andover, MA, USA) was introduced, enabling ECG acquisition during MRI scanning using conventional standard 12-lead electrode positions during MRI scanning. Though, However, the ECG signals remain susceptible to magnetohydrodynamic (MHD) effects and gradient-induced voltages (GIVs), limiting their reliability and interpretability.
This study, therefore, aims to systematically characterize ECG distortion patterns and develop validated noise-reduction strategies. To this end, 12-lead ECGs will be recorded from patients undergoing routine CMR to establish a database encompassing diverse pulse sequences and clinical conditions.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous 12-lead ECG recordings will be measured during cardiac MRI scans, using the MiRTLE Medical system. In addition, a reference clean ECGs will be measured outside the MRI environment.
Time frame: 2 years
ECG signal quality can be measured by the root-mean-squared error (RMSE) and cross-correlation between the reference and in-bore MRI recordings. ECG signal quality is compromised by the magnetohydrodynamic (MHD) effect and gradient-induced voltages (GIVs). Both contributions will be quantified separately, and dedicated mitigation strategies will be developed and evaluated to reduce their impact on ECG quality.
Contact information is provided by the study sponsor or research team.
University of Calgary
Other
Acronym: C-MORE
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