A Prospective Research Investigation of Ischemia Using MCG

Not yet recruiting

• Conditions: Acute Coronary Syndrome
• Interventions: Device: Sponsor MCG device (CardiAQ)

• 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

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-25
• Study Start: 2024-07
• Study First Posted: 2024-07-01
• Last Update Posted: 2024-07-01
• Primary Completion: 2025-03
• Study Completion: 2025-06

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

Arm && Interventions

Group	Intervention	Description
ACS	Sponsor MCG device (CardiAQ)	Adult patients who are undergoing a diagnostic angiography or revascularization procedure for the diagnosis or treatment of ischemia or acute coronary syndrome (ACS). Patients are further classified as having low, medium, and high risk for ACS.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Sponsor MCG device safety	30 days	Device-related adverse events

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States