"Discovery2" Study of Using MCG at Emergency Departments

NCT07822581 | Not Yet Recruiting FDA Device

• 1 other identifier: SB-ACS-006
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease (CAD); Chest Pain; NSTE-ACS (NSTEMI and UA); Acute Coronary Syndromes (ACS)

Keywords

Magnetocardiography (MCG)

Outcome Measures

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).

  Up to 30 Days

Secondary Outcomes (1)

• Changes in MCG over time

  Day 1

Interventions

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.

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• SB Technology, Inc.: lead

Study Sites (1)

UCSF - Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease; Chest Pain; Non-ST Elevated Myocardial Infarction

Interventions

Magnetocardiography

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Magnetometry; Investigative Techniques

Study Officials

• Kit Yee Au-Yeung, PhD

  SB Technology, Inc.

  STUDY DIRECTOR

Central Study Contacts

Maggie LeDang

CONTACT

408-981-8754; clinical-trials@sandboxquantum.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 16, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-08

Locations

US (1)