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

Study Overview
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Brief Summary
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The study is a prospective multi-centre observational study to evaluate a portable magnetocardiograph device for the rule-out of acute coronary syndrome (ACS) in patients who present to the emergency department with chest pain and other symptoms consistent with ACS.

Detailed Description
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Few, if any, studies have evaluated the rule-out (R/O) of non-ST-segment elevation (NSTE) ACS which requires the sensitivity and negative predictive value (NPV) of the test to approach 100%. An alternative triage approach, utilizing a portable magnetocardiography (MCG) instrument in the emergency setting, may lead to a more accurate R/O for NSTEMI, UA, and clinically significant non-ACS coronary artery disease (CAD), in patients presenting to the ED with chest pain. MCG in the emergency setting is a new use of this non-invasive technique and may serve as an adjunctive aid that can improve cardiac triage for NSTE ACS and clinically significant CAD.This raises the research question of whether MCG may be useful for the early triage of patients with acute chest pain. In the study protocol, a clinical evaluation is defined that will assess the ability of a portable MCG instrument, using a fixed algorithm, to R/O ACS, with improved safety (i.e. << 2% false negative rate) in patients presenting to an emergency setting with chest pain.

Official Title
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A Prospective Multi-centre Observational Study to Evaluate the Diagnostic Accuracy of a Portable 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-ischaemic cause for symptoms (e.g. trauma) Haemodynamic 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 | at discharge, 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of adverse events and types |  | at discharge, 3 months follow-up | 
| All-cause mortality (divided into CV and non-CV causes) proportion |  | through 1 week and 3 months follow-up | 
| 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 |  | at discharge, 3 months follow-up | 
| MACE post-presentation to the ED (rule-out of ACS divided into MCG vs reference standard [adjudicated ACS/non-ACS diagnose]) |  | through 1 week and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, NSTE ACS, NSTEMI, Unstable Angina Pectoris, Coronary Artery Disease