Evaluation of Patients in Chest Pain in the Emergency Room

Study Overview
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Brief Summary
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The primary objective of this feasibility study is to determine whether it is possible to conduct a study of the ClearView scan among patients under evaluation for acute cardiovascular events, as well as give insight into the performance of the ClearView scoring algorithm with respect to this patient population. The EPIC™ scan is a bio-electrographic tool that may assist the health care provider in rapid assessment of the systemic origin of the patient's presenting symptom(s). The EPIC ClearView is a potentially valuable resource that may benefit an emergency department (ED) by offering expedited chest pain etiologic differentiation capabilities. The subsequent results have the potential to include more rapid chest pain patient diagnosis and appropriate disposition of non-cardiac chest pain (rule out MI); optimized precious resource expenditure (nursing, physician, inpatient or observation bed, etc.); lower costs to facility, patient and insurance company; and greater patient satisfaction rates due to decreased ED wait time.

Official Title
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Evaluation of Patients in Chest Pain in the Emergency Room

Conditions
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Acute Cardiac Ischemia

Intervention / Treatment
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* Device: ClearView Scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sex: Male or Female Age range: 18 to 85 Chief complaint upon admission to the ED: chest pain The patient or legal representative is able to understand and provide signed consent for the procedure. Every effort will be given to balance subjects by gender, age, and race. Exclusion Criteria: Patients < 18 years in age or > 85 years in age. Inability or unwillingness to provide informed consent. Patients with pacemakers or another electrical device, such as an automatic internal cardiac defibrillator, implanted somewhere in their body. Patients connected to an electrical device that cannot be removed (i.e. monitor). Pregnant women. Patients currently undergoing therapy for cancer of any kind. Patients missing all or part of any of their fingers. Patients with hand tremors or involuntary oscillations (shaking) of the hands that prevent clear imaging.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Emergency Department Patients<br>Patients presenting to the Emergency Department complaining of chest pain. | Device: ClearView Scan<br>* Assessment with ClearView device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement of ClearView scan versus Active (Presenting) Diagnosis | Statistical agreement will be assessed between the 0-25 ClearView Response Scale and the presenting diagnosis/diagnoses for the Emergency Department admission recorded within the medical record, on a per-subject basis. | At time of study scan (Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit.) |