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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chest pain patients presenting to the ED | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VitalScan Magnetocardiograph | Device | A passive, non-contact, mobile medical device that measures, displays, stores, and retrieves magnetic fluctuations caused by heart activity at a patient's bedside. |
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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All patients that present to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS) who are in normal sinus rhythm
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| Name | Affiliation | Role |
|---|---|---|
| Steve Goodacre, MB ChB MRCP DiplMC FCEM | University of Sheffield; Sheffield, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southmead Hospital, North Bristol NHS Trust | Bristol | United Kingdom | ||||
| Leicester Royal Infirmary, Univeristy Hospitals of Leicester NHS Trust |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D017202 | Myocardial Ischemia |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D000789 | Angina, Unstable |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
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| 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 |
| Leicester |
| LE1 5WW |
| United Kingdom |
| St George's University Hospitals NHS Foundation Trust | London | SW17 0QT | United Kingdom |
| Queens Medical Centre, Nottingham Univeristy Hospitals NHS Trust | Nottingham | NG7 2UH | United Kingdom |
| Northern General Hospital | Sheffield | S5 7AU | United Kingdom |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |