MCG Discovery Study in Emergency Departments

SB Technology

Status: Enrolling

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

Treatments: Device: Sponsor MCG device

Study type: Interventional

Funder types: Industry

Identifiers

NCT06095557

SB-ACS-002

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Sponsor MCG device

Experimental group

Description:

All participants will receive a scan from the Sponsor MCG device

Treatment:

Device: Sponsor MCG device