MCG Discovery Study in Emergency Departments
Not Applicable
Recruiting
- Conditions
- NSTEMI - Non-ST Segment Elevation MIACS - Acute Coronary Syndrome
- Interventions
- Device: Sponsor MCG device
- Registration Number
- NCT06095557
- Lead Sponsor
- SB Technology, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sponsor MCG device Sponsor MCG device All participants will receive a scan from the Sponsor MCG device
- Primary Outcome Measures
Name Time Method % analyzable Sandbox MCG data during the procedure (MCG scan) % Sandbox MCG data collected and suitable for analysis
- Secondary Outcome Measures
Name Time Method 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) heartbeats needed to obtain signal
Trial Locations
- Locations (1)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States