Actively Recruiting
A Prospective Research Investigation of Ischemia Using SandboxAQ Magnetocardiography Device
Led by SB Technology, Inc. · Updated on 2025-10-21
150
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
S
SB Technology, Inc.
Lead Sponsor
M
Mayo Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the usefulness of the CardiAQ MCG, a bedside magnetocardiography device, to study heart conditions related to acute coronary syndrome (ACS) and myocardial ischemia. This observational pilot study involves adult patients undergoing diagnostic angiography or revascularization procedures to assess their risk levels for ACS. The study aims to better understand how well the MCG device measures cardiac magnetic fields compared to standard angiography procedures. Participants use the Sponsor MCG device, which measures the heart's magnetic activity without shielding, around the time of their planned angiography or revascularization. The study classifies patients into low, medium, and high risk for ACS and collects data within 24 hours of their procedures. An additional safety follow-up on the MCG device use is conducted over 30 days. During the study, participants provide written consent and undergo the MCG measurement before their clinical heart procedure. Researchers compare MCG readings with angiography results taken within a day. Participants are monitored for device safety up to a month after use. The total study participation includes initial assessments around the procedure and follow-up safety monitoring.
CONDITIONS
Brief Title
A Prospective Research Investigation of Ischemia Using MCG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled to undergo a diagnostic angiography or revascularization procedure for the diagnosis or treatment of ischemia or acute myocardial infarction
- Ability for participant to comply with study requirements
- Patient consented before the planned, clinically indicated cath-lab procedure begins to allow sufficient time for study related activities
- Written informed consent
You will not qualify if you...
- Present STEMI
- Pregnant or breastfeeding
- Having an active atrial fibrillation episode as seen on most current 12-lead ECG
- Active thoracic metal implant
- Poor access to follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 24 hours
Participants undergo magnetocardiography using the Sponsor MCG device and a diagnostic angiography or revascularization procedure to assess ischemia or acute coronary syndrome.
1 to 2 visits depending on procedure scheduling
Duration - 30 days
Participants are monitored for safety related to the Sponsor MCG device following the diagnostic procedures.
Follow-up visits as needed within 30 days
Trial Site Locations
Total: 2 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
Research Team
M
Maggie LeDang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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