Magnetocardiography (MCG) Device Use in Patients With Elevated Troponin
Not Applicable
Completed
- Conditions
- ACS - Acute Coronary Syndrome
- Interventions
- Device: Sponsor MCG deivce
- Registration Number
- NCT06620744
- Lead Sponsor
- SB Technology, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sponsor MCG Device Sponsor MCG deivce All participants will receive a scan from the sponsor's MCG device.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Sandbox MCG safety 30-days Device-related adverse events
Trial Locations
- Locations (1)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States