NCT06095557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2025

Completed
Last Updated

October 21, 2025

Status Verified

October 1, 2025

Enrollment Period

1.6 years

First QC Date

October 12, 2023

Last Update Submit

October 17, 2025

Conditions

ACS - Acute Coronary SyndromeNSTEMI - Non-ST Segment Elevation MI

Keywords

magnetocardiographyMCG

Outcome Measures

Primary Outcomes (1)

  • % analyzable Sandbox MCG data

    % Sandbox MCG data collected and suitable for analysis

    during the procedure (MCG scan)

Secondary Outcomes (4)

  • Sandbox MCG safety

    30 days

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

    during the procedure (MCG scan)

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

    during the procedure (MCG scan)

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

    during the procedure (MCG scan)

Study Arms (1)

Sponsor MCG device

EXPERIMENTAL

All participants will receive a scan from the Sponsor MCG device

Device: Sponsor MCG device

Interventions

Sponsor MCG deviceDEVICE

unshielded device measuring cardiac magnetic fields

Sponsor MCG device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presents to ED with symptoms of Acute Coronary Syndrome (ACS)
  • Can provide written consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Acute Coronary SyndromeNon-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Kit Yee Au-Yeung, PhD

    SB Technology, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 23, 2023

Study Start

October 30, 2023

Primary Completion

June 9, 2025

Study Completion

July 8, 2025

Last Updated

October 21, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)