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NCT Number: NCT07456644

12-lead ECG Recording During Cardiac MRI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

MR-compatible 12-lead ECG recording system

Device

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.

Primary outcomes

  1. ECG signal quality during cardiac MRI

    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.

Study contacts

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

Professor dr. Götte

CONTACT

[email protected]

4039448697

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Acronym: C-MORE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

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.