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OpenTrials
Completed

NCT Number: NCT06095557

MCG Discovery Study in Emergency Departments

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.

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Key information

Conditions

ACS - Acute Coronary Syndrome Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia NSTEMI - Non-ST Segment Elevation MI Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sponsor MCG device

Device

unshielded device measuring cardiac magnetic fields

Primary outcomes

  1. % analyzable Sandbox MCG data

    Time frame: during the procedure (MCG scan)

    % Sandbox MCG data collected and suitable for analysis

Secondary outcomes

  1. Sandbox MCG safety

    Time frame: 30 days

    Device-related adverse events

  2. Characterization of scan results that may differentiate between high risk and low risk ACS patients

    Time frame: 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

    Time frame: 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

    Time frame: during the procedure (MCG scan)

    heartbeats needed to obtain signal

Sponsors and collaborators

Lead sponsor

SB Technology, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2023
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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