"Discovery2" Study of Using MCG at Emergency Departments

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorSB Technology, Inc.

About this trial

The purpose of this research is to collect the magnetic signals from the heart to identify features that may help Emergency Department (ED) doctors differentiate high and low risk patients for heart related chest pain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women and men aged 22 years and older

Participant presenting with signs and symptoms suggestive of NSTE-ACS

In ED chest pain/NSTE-ACS care pathway

HEART Score 4+

Disqualifiers

Unable to provide informed consent

ST elevation myocardial infarction (STEMI)

Active arrhythmia (as seen on the most recent ECG) such as atrial fibrillation, atrial flutter, ventricular tachycardia

Acute hemodynamic instability

Trial population

Adult patients in the ED presenting with symptoms suggestive of acute coronary syndromes, with a HEART Score of 4 or above, and after the first ECG and troponin results have been obtained to rule-out STEMI or obvious non-ACS are potential candidates for this study. This represents the "grey-zone", suspected non-ST-elevation acute coronary syndrome (NSTE-ACS) patient population that is time-consuming to triage and often creates a bottleneck in the ED.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Magnetocardiography

    Device

    The SandboxAQ CardiAQ System is an investigational device, and it is intended to non-invasively measure and display the magnetic signals produced by the electric currents in the heart. Its purpose is to assist in the evaluation of myocardial ischemia and infarction risks, in patients with symptoms suggestive of ACS. It is intended to complement clinical judgment and to augment standard of care diagnostic tools.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Training machine learning algorithms.

The main objective of the study is to collect MCG and other clinical data from the intended patient population for training machine learning algorithms to identify the presence of High Risk - Coronary Artery Disease (HRCAD).

Time frame
Up to 30 Days

Secondary outcomes

1

Changes in MCG over time

The second objective is to characterize changes in MCG, if any, over the course of a patient's evaluation workflow in the ED, with a repeat MCG scan.

Time frame
Day 1

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: