ACS - Acute Coronary Syndrome
Conditions
Keywords
magnetocardiography, MCG
Brief summary
This prospective device study will examine the feasibility of MCG data collection in a hospital setting using the SandboxAQ MCG device as a potential method to more accurately and quickly quantify cardiac disease of patients with elevated Troponin.
Interventions
Unshielded device measuring cardiac magnetic fields.
Sponsors
Study design
Eligibility
Inclusion criteria
* Received a positive hs-cTnI based on the institutions laboratory normal value ranges (e.g. female ≥14 and male ≥35)
Exclusion criteria
* Present STEMI * Having an active atrial fibrillation episode as seen on 12-lead ECG * Clear non-ischemic cause for symptoms (e.g. trauma) * Active thoracic metal implants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion (%) of all collected MCG data that meets the necessary data quality. requirements and are deemed suitable for analysis. | Per-scan, on average 5 minutes, day of enrollment | MCG Data Quality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sandbox MCG safety | 30-days | Device-related adverse events |
Countries
United States