Magnetohydrodynamic EffectC-MORENCT07456644
12-lead ECG Recording During Cardiac MRI
An observational study of Magnetohydrodynamic Effect and Gradient-induced Voltages, run by University of Calgary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Magnetohydrodynamic Effect, Gradient-induced Voltages, ECG Signal Quality, Measured Inside the MRI Bore
- What is being tested?
- MR-compatible 12-lead ECG recording system
- Type of treatment
- Medical device
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Jan 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any patient referred for CMR can qualify for this study.
Who may be able to join
- Any patient referred for CMR scan.
- At least 18 years of age.
- Able to comprehend and provide informed consent in English.
Who cannot join
- Standard contraindication for MRI.
- Younger than 18 years.
- Incapacitated.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Magnetohydrodynamic Effect, Gradient-induced Voltages, ECG Signal Quality, Measured Inside the MRI Bore
- Being tested
- MR-compatible 12-lead ECG recording system
- Keywords
- ECG during MRI, Removal MHD effect, Magnetohydrodynamic effect, 12-lead ECG during CMR, Gradient-induced voltages, Monitoring during CMR, Monitoring, iCMR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-compatible 12-lead ECG recording systemDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG signal quality during cardiac MRI
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Magnetohydrodynamic EffectStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Gotte, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456644
- Sponsor's protocol ID
- REB25-1729
- Acronym
- C-MORE
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: If required, only fully anonymized ECG recordings and MRI scans will be shared. All directly and indirectly identifiable information will be removed prior to data sharing, and no personal data will be transferred to external parties.
Publications
MiRTLE Medical L. MiRTLE Medical Product 2025. https://mirtlemed.com/product (accessed March 21, 2025).
Mason RE, Likar I. A new system of multiple-lead exercise electrocardiography. Am Heart J. 1966 Feb;71(2):196-205. doi: 10.1016/0002-8703(66)90182-7. No abstract available.
PubMed 5902099Gregory TS, Cheng R, Tang G, Mao L, Tse ZTH. The Magnetohydrodynamic Effect and its Associated Material Designs for Biomedical Applications: A State-of-the-Art Review. Adv Funct Mater. 2016 Jun 14;26(22):3942-3952. doi: 10.1002/adfm.201504198. Epub 2016 Feb 24.
PubMed 29527149Tse ZT, Dumoulin CL, Clifford GD, Schweitzer J, Qin L, Oster J, Jerosch-Herold M, Kwong RY, Michaud G, Stevenson WG, Schmidt EJ. A 1.5T MRI-conditional 12-lead electrocardiogram for MRI and intra-MR intervention. Magn Reson Med. 2014 Mar;71(3):1336-47. doi: 10.1002/mrm.24744.
PubMed 23580148Oster J, Llinares R, Payne S, Tse ZT, Schmidt EJ, Clifford GD. Comparison of three artificial models of the magnetohydrodynamic effect on the electrocardiogram. Comput Methods Biomech Biomed Engin. 2015;18(13):1400-17. doi: 10.1080/10255842.2014.909090. Epub 2014 Apr 24.
PubMed 24761753Zhang SH, Tse ZT, Dumoulin CL, Kwong RY, Stevenson WG, Watkins R, Ward J, Wang W, Schmidt EJ. Gradient-induced voltages on 12-lead ECGs during high duty-cycle MRI sequences and a method for their removal considering linear and concomitant gradient terms. Magn Reson Med. 2016 May;75(5):2204-16. doi: 10.1002/mrm.25810. Epub 2015 Jun 23.
PubMed 26101951Dos Reis JE, Soullie P, Oster J, Palmero Soler E, Petitmangin G, Felblinger J, Odille F. Reconstruction of the 12-lead ECG using a novel MR-compatible ECG sensor network. Magn Reson Med. 2019 Nov;82(5):1929-1945. doi: 10.1002/mrm.27854. Epub 2019 Jun 14.
PubMed 31199011Scott AD, Keegan J, Firmin DN. Motion in cardiovascular MR imaging. Radiology. 2009 Feb;250(2):331-51. doi: 10.1148/radiol.2502071998.
PubMed 19188310Oster J, Clifford GD. Acquisition of electrocardiogram signals during magnetic resonance imaging. Physiol Meas. 2017 Jun 22;38(7):R119-R142. doi: 10.1088/1361-6579/aa6e8c.
PubMed 28430109Si D, Littlewood SJ, Crabb MG, Phair A, Prieto C, Botnar RM. Cardiovascular magnetic resonance imaging: Principles and advanced techniques. Prog Nucl Magn Reson Spectrosc. 2025 Aug-Oct;148-149:101561. doi: 10.1016/j.pnmrs.2025.101561. Epub 2025 Feb 24.
PubMed 40912881Guo R, Weingartner S, Siuryte P, T Stoeck C, Fuetterer M, E Campbell-Washburn A, Suinesiaputra A, Jerosch-Herold M, Nezafat R. Emerging Techniques in Cardiac Magnetic Resonance Imaging. J Magn Reson Imaging. 2022 Apr;55(4):1043-1059. doi: 10.1002/jmri.27848. Epub 2021 Jul 31.
PubMed 34331487
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12-lead ECG Recording During Cardiac MRI
- ClinicalTrials.gov ID
- NCT07456644
- Acronym / sponsor ID
- C-MORE / REB25-1729
- Conditions
- Magnetohydrodynamic Effect, Gradient-induced Voltages, ECG Signal Quality, Measured Inside the MRI Bore
- Keywords
- ECG during MRI, Removal MHD effect, Magnetohydrodynamic effect, 12-lead ECG during CMR, Gradient-induced voltages, Monitoring during CMR, Monitoring, iCMR
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient referred for CMR can qualify for this study.
Key inclusion criteria (3 listed)
- Any patient referred for CMR scan.
- At least 18 years of age.
- Able to comprehend and provide informed consent in English.
Key exclusion criteria (3 listed)
- Standard contraindication for MRI.
- Younger than 18 years.
- Incapacitated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-compatible 12-lead ECG recording systemContinuous 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. | Device | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- BackgroundMiRTLE Medical L. MiRTLE Medical Product 2025. https://mirtlemed.com/product (accessed March 21, 2025).
- Background: PubMed 5902099Mason RE, Likar I. A new system of multiple-lead exercise electrocardiography. Am Heart J. 1966 Feb;71(2):196-205. doi: 10.1016/0002-8703(66)90182-7. No abstract available.
- Background: PubMed 29527149Gregory TS, Cheng R, Tang G, Mao L, Tse ZTH. The Magnetohydrodynamic Effect and its Associated Material Designs for Biomedical Applications: A State-of-the-Art Review. Adv Funct Mater. 2016 Jun 14;26(22):3942-3952. doi: 10.1002/adfm.201504198. Epub 2016 Feb 24.
- Background: PubMed 23580148Tse ZT, Dumoulin CL, Clifford GD, Schweitzer J, Qin L, Oster J, Jerosch-Herold M, Kwong RY, Michaud G, Stevenson WG, Schmidt EJ. A 1.5T MRI-conditional 12-lead electrocardiogram for MRI and intra-MR intervention. Magn Reson Med. 2014 Mar;71(3):1336-47. doi: 10.1002/mrm.24744.
- Background: PubMed 24761753Oster J, Llinares R, Payne S, Tse ZT, Schmidt EJ, Clifford GD. Comparison of three artificial models of the magnetohydrodynamic effect on the electrocardiogram. Comput Methods Biomech Biomed Engin. 2015;18(13):1400-17. doi: 10.1080/10255842.2014.909090. Epub 2014 Apr 24.
- Background: PubMed 26101951Zhang SH, Tse ZT, Dumoulin CL, Kwong RY, Stevenson WG, Watkins R, Ward J, Wang W, Schmidt EJ. Gradient-induced voltages on 12-lead ECGs during high duty-cycle MRI sequences and a method for their removal considering linear and concomitant gradient terms. Magn Reson Med. 2016 May;75(5):2204-16. doi: 10.1002/mrm.25810. Epub 2015 Jun 23.
- Background: PubMed 31199011Dos Reis JE, Soullie P, Oster J, Palmero Soler E, Petitmangin G, Felblinger J, Odille F. Reconstruction of the 12-lead ECG using a novel MR-compatible ECG sensor network. Magn Reson Med. 2019 Nov;82(5):1929-1945. doi: 10.1002/mrm.27854. Epub 2019 Jun 14.
- Background: PubMed 19188310Scott AD, Keegan J, Firmin DN. Motion in cardiovascular MR imaging. Radiology. 2009 Feb;250(2):331-51. doi: 10.1148/radiol.2502071998.
- Background: PubMed 28430109Oster J, Clifford GD. Acquisition of electrocardiogram signals during magnetic resonance imaging. Physiol Meas. 2017 Jun 22;38(7):R119-R142. doi: 10.1088/1361-6579/aa6e8c.
- Background: PubMed 40912881Si D, Littlewood SJ, Crabb MG, Phair A, Prieto C, Botnar RM. Cardiovascular magnetic resonance imaging: Principles and advanced techniques. Prog Nucl Magn Reson Spectrosc. 2025 Aug-Oct;148-149:101561. doi: 10.1016/j.pnmrs.2025.101561. Epub 2025 Feb 24.
- Background: PubMed 34331487Guo R, Weingartner S, Siuryte P, T Stoeck C, Fuetterer M, E Campbell-Washburn A, Suinesiaputra A, Jerosch-Herold M, Nezafat R. Emerging Techniques in Cardiac Magnetic Resonance Imaging. J Magn Reson Imaging. 2022 Apr;55(4):1043-1059. doi: 10.1002/jmri.27848. Epub 2021 Jul 31.
- Individual participant dataSharing planned: Undecided. If required, only fully anonymized ECG recordings and MRI scans will be shared. All directly and indirectly identifiable information will be removed prior to data sharing, and no personal data will be transferred to external parties.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Magnetohydrodynamic Effect and Gradient-induced Voltages, run by University of Calgary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor dr. Götte (4039448697, marco.gotte@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG signal quality during cardiac MRI (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07456644, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.