Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients
| Status: | Completed |
|---|---|
| Conditions: | Angina, Cardiology, Cardiology, Hospital |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/2/2018 |
| Start Date: | July 15, 2017 |
| End Date: | May 1, 2018 |
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.
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.
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. Positive response on MCG Pre-Screening Form (for implanted metallic objects)
5. Atrial fibrillation (AF) with rapid ventricular response (RVR)
6. Patients with claustrophobia or unable to lie supine for 2 minutes
7. Pregnant women
8. Poor candidate for follow-up (e.g. no access to phone)
9. Prisoners
10. Repeat participants
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