Evaluation of MRI-conditional 12-lead ECG

NCT04247685 | Recruiting

• 1 other identifier: 314-2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 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: 1. indicating 12-lead ecg quality is substantially worse than 3-lead ecg 2. somewhat worse 3. equivalent 4. somewhat better 5. significantly better

  up to 6 weeks

Study Arms (2)

12-Lead ECG

EXPERIMENTAL

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)

3-lead ECG gating system

ACTIVE COMPARATOR

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

Device: 3-lead ECG gating system

Interventions

12-lead ECG monitoring device (MiRTLE Medical) DEVICE

12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical is the experimental device;

12-Lead ECG

3-lead ECG gating system DEVICE

3-lead ECG gating system is the placebo/standard of care

3-lead ECG gating system

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• Atrial fibrillation
• Provision of informed consent
• Eligible for the Ontario Health Insurance Plan

You may not qualify if:

• Failure to provide informed consent
• Pregnant women
• CMR contra-indicated
• Hemodynamically unstable
• Permanent pacemaker/ICD
• Aneurysm clip/carotid artery vascular clamp
• Claustrophobic

Sponsors & Collaborators

• Dr. Graham Wright: lead

Study Sites (1)

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mary Li, MSc

CONTACT

4164806100; mary.li@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior scientist

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: January 30, 2020
• Study Start: January 18, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)