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Набор скоро начнётся NCT07456644

12-lead ECG Recording During Cardiac MRI

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: MR-compatible 12-lead ECG recording system.
Кому может быть актуально
Состояния в реестре: Magnetohydrodynamic Effect, Gradient-induced Voltages, ECG Signal Quality, Measured Inside the MRI Bore. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство MR-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.

Первичные конечные точки

  • ECG signal quality during cardiac MRI [Срок оценки: 2 years]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • 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. PMID 5902099
  • Gregory 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. PMID 29527149
  • Tse 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. PMID 23580148
  • Oster 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. PMID 24761753
  • Zhang 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. PMID 26101951
  • Dos 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. PMID 31199011
  • Scott AD, Keegan J, Firmin DN. Motion in cardiovascular MR imaging. Radiology. 2009 Feb;250(2):331-51. doi: 10.1148/radiol.2502071998. PMID 19188310

Идентификаторы

NCT: NCT07456644 · REB25-1729

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗