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12-lead ECG Recording During Cardiac MRI

12-lead ECG Recording During Cardiac MRI

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07456644
Acronym
C-MORE
Enrollment
2500
Registered
2026-03-06
Start date
2026-03-01
Completion date
2028-01-01
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ECG Signal Quality, Measured Inside the MRI Bore, Gradient-induced Voltages, Magnetohydrodynamic Effect

Keywords

ECG during MRI, Removal MHD effect, Magnetohydrodynamic effect, 12-lead ECG during CMR, Gradient-induced voltages, Monitoring during CMR, Monitoring, iCMR

Brief summary

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.

Detailed description

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.

Interventions

DEVICEMR-compatible 12-lead ECG recording system

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.

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Any patient referred for CMR scan. * At least 18 years of age. * Able to comprehend and provide informed consent in English.

Exclusion criteria

* Standard contraindication for MRI. * Younger than 18 years. * Incapacitated.

Design outcomes

Primary

MeasureTime frameDescription
ECG signal quality during cardiac MRI2 yearsECG 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.

Contacts

CONTACTProfessor dr. Götte
marco.gotte@ucalgary.ca4039448697

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026