Magnetocardiography (MCG) Device Use in Patients with Elevated Troponin (DUET)

SB Technology

Status: Not yet enrolling

Conditions: ACS - Acute Coronary Syndrome

Treatments: Device: Sponsor MCG deivce

Study type: Interventional

Funder types: Industry

Identifiers

NCT06620744

SB-ACS-004

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Present STEMI
• Having an active atrial fibrillation episode as seen on 12-lead ECG
• Clear non-ischemic cause for symptoms (e.g. trauma)
• Active thoracic metal implants

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Sponsor MCG Device

Experimental group

Description:

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

Treatment:

Device: Sponsor MCG deivce