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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Magnetocardiography
DeviceThe 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
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: