Acute Coronary Syndromes (ACS), Chest Pain, Coronary Artery Disease (CAD), NSTE-ACS (NSTEMI and UA)
Conditions
Keywords
Magnetocardiography (MCG)
Brief summary
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.
Interventions
DEVICEMagnetocardiography
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.
Sponsors
SB Technology, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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+ * Have received their first troponin result and can accommodate an MCG scan before the second troponin result.
Exclusion criteria
* 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 * Inability to lie supine and still for 5-10 minutes * Known or suspected pregnancy * Unable or unwilling to comply with required follow-up * Metallic passive implants that would make the participant unsuitable for MCG (e.g. spinal implants, metal shoulder replacements, dental implants.. etc.) * Active implantable medical devices (e.g. pacemakers, neurostimulators.. etc.) * Active illegal drug use per history of present illness * Contraindicated for temporary removal of telemetry during MCG scan * Clear non-ischemic cause for symptoms (e.g. trauma, viral infection, valve disease) * Clinical conditions that in the opinion of the Investigator would compromise the safety of the participant or ability to complete the protocol (e.g., exceeds bed weight limit, allergy to adhesives)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Training machine learning algorithms. | Up to 30 Days | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in MCG over time | Day 1 | 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. |
Countries
United States
Contacts
CONTACTMaggie LeDang
STUDY_DIRECTORKit Yee Au-Yeung, PhD
SB Technology, Inc.
Outcome results
None listed