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临床试验/NCT07456644
NCT07456644尚未招募不适用

12-lead ECG Recording During Cardiac MRI

University of Calgary0 个研究点目标入组 2,500 人开始时间: 2026年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
2,500
主要终点
ECG signal quality during cardiac MRI

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

ECG signal quality during cardiac MRI

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Gotte

Professor dr.

University of Calgary

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