MCG Discovery Study in Emergency Departments

Not Applicable

Recruiting

• Conditions: NSTEMI - Non-ST Segment Elevation MI; ACS - Acute Coronary Syndrome

• 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

Study Timeline

• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-23
• Study Start: 2023-10-30
• Status Verified: 2024-06
• Primary Completion: 2025-06
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-05
• Study Completion: 2025-07

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

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