Acute Coronary Syndrome
Conditions
Keywords
Magnetocardiography, MCG
Brief summary
PRISM is a prospective, pilot research study that aims to systematically characterize the usefulness of CardiAQ MCG, a bedside magnetocardiography device, in the evaluation of myocardial ischemia and infarction status.
Interventions
DEVICESponsor MCG device (CardiAQ)
Unshielded magnetocardiography device for measuring cardiac magnetic fields
Sponsors
SB Technology, Inc.
Mayo Clinic
Icahn School of Medicine at Mount Sinai
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relationship between pre-procedural MCG and the peri-procedural angiography-based measures | Data taken within 24 hours of each other | Utilize linear regression and logistic regression to determine whether a set of a priori MCG-based biomarkers can prospectively predict the objective clinical assessment of ACS, while statistically adjusting for covariates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sponsor MCG device safety | 30 days | Device-related adverse events |
Countries
United States
Contacts
CONTACTMaggie LeDang
STUDY_DIRECTORKit Yee Au-Yeung, PhD
SB Technology, Inc.
Outcome results
None listed