A Prospective Research Investigation of Ischemia Using MCG (PRISM/PRISM2)

SB Technology

Status: Enrolling

Conditions: Acute Coronary Syndrome

Treatments: Device: Sponsor MCG device (CardiAQ)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06481943

SB-ACS-003, SB-ACS-005

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

ACS

Description:

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.

Treatment:

Device: Sponsor MCG device (CardiAQ)