Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients

Study Overview
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Brief Summary
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Genetesis is a cardiac diagnostics company which presents a novel magnetocardiogram (MCG) analysis system called CardioFlux. This investigation presents a new, noninvasive diagnostic option to use MCG for rapid diagnosis of acute coronary syndrome. Data from the Cardioflux system will be compared with stress testing methods as well as the results of cardiac catheterization to identify patients with myocardial ischemia. This is a prospective observational single-blinded convenience pilot study of 100 patients placed in the Clinical Decision Unit (CDU) for evaluation of chest pain at St. John Hospital and Medical Center (Detroit, MI). Patients enrolled in the study will also have a 30 and 180 day follow up for analysis of adverse cardiac events.

Official Title
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Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients

Conditions
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Acute Coronary Syndrome, Myocardial Infarction

Intervention / Treatment
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* Diagnostic Test: Magnetocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low and intermediate risk ED patients presenting with chest pain of possible cardiac origin who have a negative first troponin result and non-diagnostic ECG that are to be placed in the Cardiac Diagnostic Unit (CDU) for further evaluation. Exclusion Criteria: ≤ 18 years of age Patients unable to fit into device Non-ambulatory patients Patients with any implantable device or metal in the thorax area (e.g. pacemaker, AICD, bullet fragments in thorax) Patients with claustrophobia Pregnant women Poor candidate for follow-up Prisoners Repeat participants

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute Chest pain<br>All patients admitted to the Clinical Decision Unit presenting to the Emergency Department (ED) with chest pain with risk factors suggesting a possible cardiac etiology. | Diagnostic Test: Magnetocardiography<br>* Study subjects will be placed within a magnetic shielding apparatus. Noninvasive sensors placed over the subject's torso will acquire magnetic field fluctuations generated by cardiac activity, which will then be analyzed for evidence of myocardial ischemia.<br>* Other names: Cardioflux Scan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of Active Myocardial Ischemia | Comparison of Magnetocardiography (MCG) and imaging of myocardial magnetic field/current will be performed directly with standard stress testing protocols performed on patients admitted to a cardiac observation unit. | 2 days | 
| Identification of Active Myocardial Ischemia | Comparison of Magnetocardiography (MCG) and imaging of magnetic field/current will be directly compared to cardiac catheterization data in those patients who undergo this procedure. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medium term Adverse Cardiac Events | In patients discharged from the cardiac observation unit with a negative stress test result, how does MCG results correlate with major adverse cardiac events (MACE) at 30 days and 6 months following discharge? MACE will be defined as acute myocardial infarction, coronary revascularization, and all-cause death. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetocardiography, Chest pain