VitalScan MCG Rule-out Multi-centre Pivotal Study - US

Study Overview
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Brief Summary
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A prospective multi-centre observational study to validate the diagnostic accuracy of a transportable magnetocardiograph device for acute coronary syndrome (ACS), focusing on rule-out capability, in patients who present to the emergency department with chest pain symptoms consistent with ACS.

Official Title
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A Prospective Multi-centre Observational Study to Validate the Diagnostic Accuracy of a Transportable Magnetocardiograph Device for Acute Coronary Syndrome (ACS), Focusing on Rule-out Capability, in Patients Who Present to the Emergency Department With Chest Pain Symptoms Consistent With ACS

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Device: VitalScan Magnetocardiograph


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient presents to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS) 18+ year old male or female Patient is willing and able to give written informed consent Exclusion Criteria: ST-segment Elevation MI (STEMI) Clear non-ischemic cause for symptoms (e.g. trauma) Hemodynamic instability on admission (e.g. BP>220mmHg systolic & >110mmHg diastolic, <80mmHg systolic & <40mmHg diastolic, HR>160bpm) Ventricular tachycardia or fibrillation that cannot be treated effectively Atrial fibrillation Thoracic metal implants Pacemaker or internal defibrillator Pregnancy (if after 20-week period)* or lactation Patient unable to lie down (i.e. supine position) or stay still on the examination bed Patient unable to understand the informed consent process and/or has a poor understanding of English (e.g. English- speaking relative/translator not available) Patient unable to comply with the requirements of the protocol

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 |
| --- | --- |
| Chest pain patients presenting to the ED<br>All patients that present to the emergency department with chest pain and potentially other symptoms consistent with ACS and meet all eligibility criteria will undergo VitalScan Magnetocardiograph. | Device: VitalScan Magnetocardiograph<br>* A passive, non-contact, mobile medical device that measures, displays, stores, and retrieves magnetic fluctuations caused by heart activity at a patient's bedside.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of MCG | Sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm | up to 3 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of adverse events and types |  | up to 3 month follow-up | 
| All-cause mortatility (divided into CV and non-CV causes) proportion |  | through 1 week, 3 month follow-up | 
| 3.Change in sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm, according to low, intermediate and high PTP groups |  | up to 3 months follow-up | 
| MACE post-presentation to the ED (rule-out of ACS divided into MCG vs reference standard (adjudicated ACS/non-ACS diagnoses)) |  | through 1 week, 3 month follow-up |