Evaluating a new device for heart condition diagnosis
A Prospective Research Investigation of Ischemia Using SandboxAQ Magnetocardiography Device
SB Technology, Inc. · NCT06481943
This study is testing a new device to see if it can help doctors better diagnose heart problems in patients who are already scheduled for heart procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SB Technology, Inc. (industry) |
| Locations | 2 sites (Rochester, Minnesota and 1 other locations) |
| Trial ID | NCT06481943 on ClinicalTrials.gov |
What this trial studies
This pilot research study aims to assess the effectiveness of the CardiAQ magnetocardiography (MCG) device in diagnosing myocardial ischemia and infarction. Participants scheduled for diagnostic angiography or revascularization procedures will be monitored using this bedside device to gather data on its utility. The study seeks to systematically characterize the device's performance in a clinical setting, providing insights into its potential role in acute coronary syndrome management.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for diagnostic angiography or revascularization due to ischemia or acute myocardial infarction.
Not a fit: Patients experiencing STEMI, pregnant or breastfeeding individuals, and those with active atrial fibrillation or thoracic metal implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic capabilities for patients with acute coronary syndrome, leading to better treatment outcomes.
How similar studies have performed: While this approach is innovative, similar studies using magnetocardiography have shown promise in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Rochester, Minnesota and 1 other locations
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
- Mount Sinai Hospital — New York, New York, United States (RECRUITING)
Study contacts
- Study coordinator: Maggie LeDang
- Email: clinical-trials@sandboxquantum.com
- Phone: 408-981-8754
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Coronary Syndrome, Magnetocardiography, MCG