ACS - Acute Coronary Syndrome, NSTEMI - Non-ST Segment Elevation MI
Conditions
Keywords
magnetocardiography, MCG
Brief summary
This prospective discovery study is designed to demonstrate the feasibility of using an unshielded, mobile MCG device in an Emergency Department (ED) setting. The main question it aims to answer is whether interpretable data can be reliably collected as part of an ED workflow.
Interventions
DEVICESponsor MCG device
unshielded device measuring cardiac magnetic fields
Sponsors
SB Technology, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presents to ED with symptoms of Acute Coronary Syndrome (ACS) * Can provide written consent
Exclusion criteria
* Presents to ED with ST-Elevation Myocardial Infarction (STEMI) * Presents to ED with Atrial Fibrillation * Clear non-ischemic cause for symptoms (i.e. trauma) * Active thoracic metal implants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % analyzable Sandbox MCG data | during the procedure (MCG scan) | % Sandbox MCG data collected and suitable for analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sandbox MCG safety | 30 days | Device-related adverse events |
| Characterization of scan results that may differentiate between high risk and low risk ACS patients | during the procedure (MCG scan) | Signal Noise Ratio of ECG features |
Countries
United States
Outcome results
None listed