Magnetocardiography (MCG) Device Use in Patients With Elevated Troponin

Not Applicable

Completed

• Conditions: ACS - Acute Coronary Syndrome

• Registration Number: NCT06620744
• Lead Sponsor: SB Technology, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study Start: 2024-09-21
• Study First Submitted QC: 2024-09-26
• Study First Posted: 2024-10-01
• Primary Completion: 2025-04-15
• Study Completion: 2025-04-15
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion (%) of all collected MCG data that meets the necessary data quality. requirements and are deemed suitable for analysis.	Per-scan, on average 5 minutes, day of enrollment	MCG Data Quality

Secondary Outcome Measures

Name	Time	Method
Sandbox MCG safety	30-days	Device-related adverse events

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States