Acute Coronary Syndrome CardioFlux TM Study (ACCMED)
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Approximately 16.5 million people suffer from coronary artery disease (CAD) and about 10 million present each year to emergency departments with symptoms like chest pain and shortness of breath, commonly suggestive of acute coronary syndrome (ACS). To clinically assess ACS risk in these patients, there are typically 2-6 hours of emergency room evaluation, followed by 6-42 hours of an observation period prior to discharge. The clinical pathway includes: 1) 1-3 ECG's; 2) serial troponins (1 and 3 hours vs 1 and 6 hours); and 3) other pertinent diagnostic information, including but not limited to echocardiography, stress testing and/or CT Angiography. Patients who are evaluated, have presented with a low risk for ACS, and maintain negative diagnostic results can potentially be discharged within 6 hours. However, 20%-40% of patients who fall into indeterminate diagnostic categories will require longer observation periods or admission of 12-48 hours which result in the use of expensive imaging and provocative testing, such as stress testing. The purpose of ACCMED is to measure the efficacy of Magnetocardiography (MCG) as a diagnostic tool to rule-in/rule-out myocardial ischemia in patients with suspicion of an acute coronary syndrome who have a HEART Score > 2 and to allow safe and timely disposition of the patient to an appropriate level of care.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
All patients presenting to the ED with symptoms of potential ACS and fitting the eligibility/exclusion criteria will be approached for accrual
≥ 18 years of age at the time of enrollment.
Patient presenting acutely with signs and symptoms suggestive of ACS.
Informed Consent Form signed by subject or LAR.
HEART Score of >2.
Patient enrolled within 4 hours of the beginning of the clinical assessment (exclusive of any screening examination) for suspected ACS by an appropriately credentialed clinician.
< 18 years of age.
Unable to fit into device.
Positive response on MCG metal checklist.
Deemed hemodynamically unstable by treating physician, regardless of cause.
Unable to lie supine for up to 5 minutes.
Poor candidate for follow-up (e.g., no access to phone).