Evaluation of MRI-conditional 12-lead ECG

Sponsor

Dr. Graham Wright (Other)

Overall Status

Recruiting

CT.gov ID

NCT04247685

Collaborator

(none)

Enrollment

Location

Arms

34.4

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: 12-lead ECG monitoring device (MiRTLE Medical) Device: 3-lead ECG gating system	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Other

Official Title:

Evaluation of MRI-conditional 12-lead ECG

Actual Study Start Date :

Jan 18, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 12-Lead ECG

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)

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

Active Comparator: 3-lead ECG gating system

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

Device: 3-lead ECG gating system

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

Outcome Measures

Primary Outcome Measures

absolute numbers and percentages [up to 6 weeks]
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.)
qualitatively comparison with a standard scale [up to 6 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunnybrook Health Sciences Center	Toronto	Ontario	Canada	M4N 3M5

Sponsors and Collaborators

Dr. Graham Wright

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Graham Wright, Senior scientist, Sunnybrook Health Sciences Centre

ClinicalTrials.gov Identifier:

NCT04247685

Other Study ID Numbers:

314-2019

First Posted:

Jan 30, 2020

Last Update Posted:

Mar 18, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Mar 18, 2021