A Prospective Research Investigation of Ischemia Using MCG

ConditionAcute Coronary Syndrome

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorSB Technology, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Present STEMI

Pregnant or breastfeeding

Having an active atrial fibrillation episode as seen on most current 12-lead ECG

Active thoracic metal implant

Trial population

Adult patients who are undergoing a diagnostic angiography or revascularization procedure for the diagnosis or treatment of ischemia or acute coronary syndrome (ACS).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Sponsor MCG device (CardiAQ)
Device
Unshielded magnetocardiography device for measuring cardiac magnetic fields

Treatment groups

335 Participants

are divided into 1 treatment group

Group A: ACS1 intervention

Trial outcomes

Primary outcomes

Relationship between pre-procedural MCG and the peri-procedural angiography-based measures

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.

Time frame

Data taken within 24 hours of each other

Secondary outcomes

Sponsor MCG device safety

Device-related adverse events

Time frame

30 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SB Technology, Inc.

Lead sponsor

Mayo Clinic

Collaborator

Icahn School of Medicine at Mount Sinai