Magnetocardiography (MCG) Device Use in Patients With Elevated Troponin

NCT ID: NCT06620744

Last Updated: 2025-06-05

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-21

Study Completion Date

2025-04-15

Brief Summary

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This prospective device study will examine the feasibility of MCG data collection in a hospital setting using the SandboxAQ MCG device as a potential method to more accurately and quickly quantify cardiac disease of patients with elevated Troponin.

Detailed Description

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Conditions

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ACS - Acute Coronary Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sponsor MCG Device

All participants will receive a scan from the sponsor's MCG device.

Group Type EXPERIMENTAL

Sponsor MCG deivce

Intervention Type DEVICE

Unshielded device measuring cardiac magnetic fields.

Interventions

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Sponsor MCG deivce

Unshielded device measuring cardiac magnetic fields.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Received a positive hs-cTnI based on the institutions laboratory normal value ranges (e.g. female ≥14 and male ≥35)

Exclusion Criteria

* Present STEMI
* Having an active atrial fibrillation episode as seen on 12-lead ECG
* Clear non-ischemic cause for symptoms (e.g. 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-004

Identifier Type: -

Identifier Source: org_study_id

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