MCG Discovery Study in Emergency Departments

NSTEMI - Non-ST Segment Elevation MI Clinical Trial

Official title:

Discovery Study of Using a Magnetocardiography (MCG) Device at Emergency Departments (EDs)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06095557
• Other study ID #: SB-ACS-002
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: March 2024

Study information

• Verified date: November 2023
• Source: SB Technology, Inc.
• Contact: Frances Lu
• Phone: 650-722-8682
• Email: clinical-trials[@]sandboxquantum.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ACS - Acute Coronary Syndrome
• Acute Coronary Syndrome
• Emergencies
• NSTEMI - Non-ST Segment Elevation MI

Intervention

Device:
• Sponsor MCG device
unshielded device measuring cardiac magnetic fields

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
SB Technology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% analyzable Sandbox MCG data	% Sandbox MCG data collected and suitable for analysis	during the procedure (MCG scan)
Secondary	Sandbox MCG safety	Device-related adverse events	30 days
Secondary	Characterization of scan results that may differentiate between high risk and low risk ACS patients	Signal Noise Ratio of ECG features	during the procedure (MCG scan)
Secondary	Characterization of scan results that may differentiate between high risk and low risk ACS patients	t-wave field maximum angle	during the procedure (MCG scan)
Secondary	Characterization of scan results that may differentiate between high risk and low risk ACS patients	heartbeats needed to obtain signal	during the procedure (MCG scan)