NCT06620744

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

September 21, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

June 5, 2025

Status Verified

September 1, 2024

Enrollment Period

7 months

First QC Date

September 20, 2024

Last Update Submit

June 2, 2025

Conditions

ACS - Acute Coronary Syndrome

Keywords

magnetocardiographyMCG

Outcome Measures

Primary Outcomes (1)

  • Proportion (%) of all collected MCG data that meets the necessary data quality. requirements and are deemed suitable for analysis.

    MCG Data Quality

    Per-scan, on average 5 minutes, day of enrollment

Secondary Outcomes (1)

  • Sandbox MCG safety

    30-days

Study Arms (1)

Sponsor MCG Device

EXPERIMENTAL

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

Device: Sponsor MCG deivce

Interventions

Sponsor MCG deivceDEVICE

Unshielded device measuring cardiac magnetic fields.

Sponsor MCG Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Kit Yee Au-Yeung, PhD

    SB Technology, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2024

First Posted

October 1, 2024

Study Start

September 21, 2024

Primary Completion

April 15, 2025

Study Completion

April 15, 2025

Last Updated

June 5, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)