MRI-Compatible 12-Lead ECG for Heart Monitoring

Overseen By Mary Li, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Graham Wright

Disqualifiers: Pregnancy, Pacemaker, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new heart monitoring system designed to work safely during MRI scans. The aim is to determine if a 12-lead ECG monitoring system (MRI-conditional, MiRTLE Medical), which records more detailed heart activity, can better detect heart problems like arrhythmias during these scans compared to the usual 3-lead ECG gating system. People with atrial fibrillation, a common type of irregular heartbeat, who qualify for the Ontario Health Insurance Plan might be suitable for this trial. The researchers aim to improve heart monitoring during MRI exams with this new system. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance heart monitoring technology.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this MRI-conditional 12-lead ECG monitoring system is safe for heart monitoring during MRI exams?

Research shows that the MRI-conditional 12-lead ECG system from MiRTLE Medical is safe and effective during MRI scans. This system prevents interference from MRI machines that can disrupt heart monitoring signals. Studies indicate it provides clear and reliable heart information even when MRI machines are in use.

The device is MRI-compatible, meaning it operates safely in the magnetic environment of an MRI without harming patients or affecting the MRI's performance. Research has not reported any serious side effects or safety issues with this system, suggesting it is well-tolerated by patients during MRI exams.

Overall, evidence supports the safety of the MRI-conditional 12-lead ECG system for use in these situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MRI-compatible 12-lead ECG monitoring system because it allows for more comprehensive heart monitoring during MRI scans than the standard 3-lead ECG gating system. This new system from MiRTLE Medical is designed to be MRI-conditional, meaning it can safely function in the magnetic environment of an MRI scanner, providing a complete 12-lead view of heart activity. This advancement could lead to more accurate diagnoses and better patient outcomes, as it offers a fuller picture of cardiac health without interrupting MRI procedures.

What evidence suggests that this MRI-conditional 12-lead ECG monitoring system is effective for heart monitoring during MRI?

Research has shown that the MRI-conditional 12-lead ECG system, which participants in this trial may receive, represents a significant advancement in heart monitoring during MRI scans. This system detects heart issues such as irregular heartbeats and reduced blood flow. Studies have demonstrated that it resolves interference problems caused by MRI machines, enhancing the reliability of heart monitoring. Participants in the control group will use the standard 3-lead ECG gating system. The 12-lead ECG offers a clearer and more comprehensive view of heart activity compared to the standard 3-lead ECG, potentially improving the detection and management of heart problems during MRI scans. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with atrial fibrillation who have health insurance coverage through the Ontario Health Insurance Plan. It's not suitable for those with certain metal implants, claustrophobia, pregnant women, people unstable in their blood circulation or those with a permanent pacemaker or ICD.

Inclusion Criteria

Eligible for the Ontario Health Insurance Plan

Provision of informed consent

I have been diagnosed with atrial fibrillation.

Exclusion Criteria

You are afraid of being in small or enclosed spaces.

You have a permanent pacemaker or ICD (implantable cardioverter defibrillator) in your body.

I cannot undergo CMR due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MRI with either the 12-lead ECG monitoring device or the standard 3-lead ECG gating system

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3-lead ECG gating system
• MRI-conditional 12-lead ECG monitoring system (MiRTLE Medical)

Trial Overview The study tests a new MRI-compatible 12-lead ECG monitoring device against the standard 3-lead system during cardiac MRI scans. The goal is to see if the new device can better detect heart issues without being affected by MRI interference.

How Is the Trial Designed?

Group I: 12-Lead ECG Experimental Treatment 1 Intervention

The study group patients will have MRI with 12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical

Group II: 3-lead ECG gating system Active Control 1 Intervention

the control group will have MRI with 3-lead ECG gating which is standard of care.

Who Is Running the Clinical Trial?

Dr. Graham Wright

Lead Sponsor

Trials

1

Recruited

40+

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/58456?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Evaluation of MRI-conditional 12-lead ECG - Clinical Tria... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3976440/

1.5 Tesla MRI-Conditional 12-lead ECG for MR Imaging ... “12-lead ECGs allow for rapid identification of heart disease, and are particularly important for detection of arrhythmia and acute ischemia (14). MRI- ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23580148/

A 1.5T MRI-conditional 12-lead electrocardiogram ... - PubMed The aim of this study is to develop and clinically validate a 1.5T MRI-conditional 12-lead ECG system.

4. ctv.veeva.com ctv.veeva.com/study/evaluation-of-mri-conditional-12-lead-ecg

Evaluation of MRI-conditional 12-lead ECG 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1097664724010007

Evaluation of 12-lead electrocardiogram at 0.55T for ... This study evaluated ECG interpretability in a 0.55T MRI scanner. The workflow for comparing 0.55T to higher-field MRI is shown.

6. mirtlemed.com mirtlemed.com/product

Product MiRTLE Medical manufactures a high-fidelity, MRI-compatible 12-lead ECG monitoring system, a first of its kind due to MRI induced interference.

7. mirtlemed.com mirtlemed.com/

MiRTLEMed 12-lead ECG monitor engineered to be safe while eliminating the MRI's interference · Provides vital patient health information throughout the imaging process ...