Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients

Genetesis

Status: Completed

Conditions: Acute Coronary Syndrome; Myocardial Infarction

Treatments: Diagnostic Test: Magnetocardiography

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03255772

1053362-5

Details and patient eligibility

About

Genetesis is a cardiac diagnostics company which presents a novel magnetocardiogram (MCG) analysis system called CardioFlux. This investigation presents a new, noninvasive diagnostic option to use MCG for rapid diagnosis of acute coronary syndrome. Data from the Cardioflux system will be compared with stress testing methods as well as the results of cardiac catheterization to identify patients with myocardial ischemia.

This is a prospective observational single-blinded convenience pilot study of 100 patients placed in the Clinical Decision Unit (CDU) for evaluation of chest pain at St. John Hospital and Medical Center (Detroit, MI).

Patients enrolled in the study will also have a 30 and 180 day follow up for analysis of adverse cardiac events.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Low and intermediate risk ED patients presenting with chest pain of possible cardiac origin who have a negative first troponin result and non-diagnostic ECG that are to be placed in the Cardiac Diagnostic Unit (CDU) for further evaluation.

Exclusion Criteria:

1. ≤ 18 years of age
2. Patients unable to fit into device
3. Non-ambulatory patients
4. Patients with any implantable device or metal in the thorax area (e.g. pacemaker, AICD, bullet fragments in thorax)
5. Patients with claustrophobia
6. Pregnant women
7. Poor candidate for follow-up
8. Prisoners
9. Repeat participants

Trial design

101 participants in 1 patient group

Acute Chest pain

Description:

All patients admitted to the Clinical Decision Unit presenting to the Emergency Department (ED) with chest pain with risk factors suggesting a possible cardiac etiology.

Treatment:

Diagnostic Test: Magnetocardiography