MCG Device for Acute Coronary Syndrome

(DUET Trial)

Overseen By Maggie LeDang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SB Technology, Inc.

Disqualifiers: STEMI, Atrial fibrillation, Trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kit Yee Au-Yeung, PhD

Principal Investigator

SB Technology, Inc.

Eligibility Criteria

This trial is for patients who have been diagnosed with Acute Coronary Syndrome and are currently in a hospital setting. They must have elevated Troponin levels, which indicate heart muscle damage.

Inclusion Criteria

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

Exclusion Criteria

Active thoracic metal implants

I currently have atrial fibrillation, confirmed by an ECG.

My symptoms are due to an injury, not poor blood flow.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a scan from the sponsor's MCG device to assess cardiac disease

1 day

1 visit (in-person)

Follow-up

Participants are monitored for device-related adverse events and data quality

30 days

Treatment Details

Interventions

• Sponsor MCG Device

Trial Overview The study is testing the use of a new Magnetocardiography (MCG) device by SandboxAQ to see if it can quickly and accurately measure heart disease in patients with high Troponin levels.

Participant Groups

Group I: Sponsor MCG Device Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

SB Technology, Inc.

Lead Sponsor

Trials

3

Recruited

290+