MedPath

A Prospective Research Investigation of Ischemia Using MCG

Not yet recruiting
Conditions
Acute Coronary Syndrome
Registration Number
NCT06481943
Lead Sponsor
SB Technology, Inc.
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
150
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Relationship between pre-procedural MCG and the peri-procedural angiography-based measuresData 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 Outcome Measures
NameTimeMethod
Sponsor MCG device safety30 days

Device-related adverse events

Trial Locations

Locations (1)

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Ghasaq Saleh, MD
Contact
5072552504
saleh.ghasaq@mayo.edu
Mohamad A Alkhouli, MD, MBA
Contact

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.