MCG Discovery Study in Emergency Departments

NCT ID: NCT06095557

Last Updated: 2025-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-30

Study Completion Date

2025-07-08

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sponsor MCG device

All participants will receive a scan from the Sponsor MCG device

Group Type EXPERIMENTAL

Sponsor MCG device

Intervention Type DEVICE

unshielded device measuring cardiac magnetic fields

Interventions

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Sponsor MCG device

unshielded device measuring cardiac magnetic fields

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SB Technology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kit Yee Au-Yeung, PhD

Role: STUDY_DIRECTOR

SB Technology, Inc.

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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SB-ACS-002

Identifier Type: -

Identifier Source: org_study_id

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