Evaluation of MRI-conditional 12-lead ECG

Study Overview
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Brief Summary
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With MRI's increasing role in detecting central nervous system and orthopedic diseases, patients with ischemic history are increasingly referred for MRI exams. Currently, 3-lead ECG gating systems are utilized during cardiac MRI scanning as standard of care. However, this monitoring system is often insufficient to evaluate for the development of important arrhythmias or ischemia during MRI scanning. Morevoer, MRI associated magnetic fields and radio frequency pulses can produce interference in the ECG signal that leads to non-diagnostic ECG signals. MiRTLE Medical, a Massachusetts-based medical device company, has developed a high-fidelity, MRI-conditional 12-lead ECG monitoring system. This 12-lead ECG system is a first of its kind that addresses the MRI-induced interference and safety issues. This study is to evaluate the efficacy of this 12-lead ECG system in the clinical setting. The investigators hope that this system will be helpful for image-guided therapeutics especially electrophysiology.

Official Title
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Evaluation of MRI-conditional 12-lead ECG

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: 12-lead ECG monitoring device (MiRTLE Medical)
* Device: 3-lead ECG gating system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older Atrial fibrillation Provision of informed consent Eligible for the Ontario Health Insurance Plan Exclusion Criteria: Failure to provide informed consent Pregnant women CMR contra-indicated Hemodynamically unstable Permanent pacemaker/ICD Aneurysm clip/carotid artery vascular clamp Claustrophobic

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The investigators will aim to recruit 2-3 patients per month, with a total of 40 patients over two years. These 40 patients will be assigned into two MRI groups -12-lead ECG gating system as the study group and 3-lead ECG gating system as the control group. The study group patients will have MRI with 12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical, while the control group will have MRI with 3-lead ECG gating which is standard of care. Diagnostic image quality and severity of artifact will be evaluated to compare these two groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12-Lead ECG<br>The study group patients will have MRI with 12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical | Device: 12-lead ECG monitoring device (MiRTLE Medical)<br>* 12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical is the experimental device;<br>|
| Active Comparator: 3-lead ECG gating system<br>the control group will have MRI with 3-lead ECG gating which is standard of care. | Device: 3-lead ECG gating system<br>* 3-lead ECG gating system is the placebo/standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absolute numbers and percentages | the following patient data will be collected as absolute numbers and percentages in a future Table 1: Age, Sex, Cardiovascular Risk Factors (DM, HTN, Dyslipidemia, smoking, family history of cardiovascular disease), Atrial fibrillation risk factors (CHADS-2 score; CHF, Age >75, DM, prior stroke/CVA), Prior atrial fibrillation ablation procedures, echocardiographic parameters (LVEF, Left atrial size), MRI parameters (Left ventricular end-diastolic volume, left ventricular end systolic volume, left ventricular stroke volume, LVEF, left atrial volume, right ventricular volumes and ejection fraction.) | up to 6 weeks | 
| qualitatively comparison with a standard scale | qualitatively comparison will be done for ECG signal quality and artifact between the 12-lead and 3-lead ECG arms using a standard scale. A 5 point Likert scale will be used with the below scores: indicating 12-lead ecg quality is substantially worse than 3-lead ecg somewhat worse equivalent somewhat better significantly better | up to 6 weeks |