MCG Discovery Study in Emergency Departments

• Sponsor: SB Technology, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06095557
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 20

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ACS - Acute Coronary Syndrome; NSTEMI - Non-ST Segment Elevation MI	Device: Sponsor MCG device	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Discovery Study of Using a Magnetocardiography (MCG) Device at Emergency Departments (EDs)
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sponsor MCG device All participants will receive a scan from the Sponsor MCG device	Device: Sponsor MCG device; unshielded device measuring cardiac magnetic fields

Outcome Measures

Primary Outcome Measures

1. % analyzable Sandbox MCG data [during the procedure (MCG scan)]

   % Sandbox MCG data collected and suitable for analysis

Secondary Outcome Measures

1. Sandbox MCG safety [30 days]

   Device-related adverse events

2. Characterization of scan results that may differentiate between high risk and low risk ACS patients [during the procedure (MCG scan)]

   Signal Noise Ratio of ECG features

3. Characterization of scan results that may differentiate between high risk and low risk ACS patients [during the procedure (MCG scan)]

   t-wave field maximum angle

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

• SB Technology, Inc.

Investigators

• Study Director: Kit Yee Au-Yeung, PhD, SB Technology, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SB Technology, Inc.
• ClinicalTrials.gov Identifier: NCT06095557
• Other Study ID Numbers: SB-ACS-002
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 25, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by SB Technology, Inc.: magnetocardiography; MCG
• Additional relevant MeSH terms: Acute Coronary Syndrome; Emergencies

Study Results

No Results Posted as of Oct 25, 2023