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

October 17, 2025 updated by: SB Technology, Inc.

A Prospective Research Investigation of Ischemia Using SandboxAQ Magnetocardiography Device

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Mohamad A Alkhouli, MD, MBA
        • Contact:
    • New York
      • New York, New York, United States, 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ACS
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.
Device: Sponsor MCG device (CardiAQ)
Unshielded magnetocardiography device for measuring cardiac magnetic fields

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between pre-procedural MCG and the peri-procedural angiography-based measures
Time Frame: 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.
Data taken within 24 hours of each other

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sponsor MCG device safety
Time Frame: 30 days
Device-related adverse events
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SB Technology, Inc.

Collaborators

Mayo Clinic
Icahn School of Medicine at Mount Sinai

Investigators

  • Study Director: Kit Yee Au-Yeung, PhD, SB Technology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Estimated)

October 21, 2025

Last Update Submitted That Met QC Criteria

October 17, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB-ACS-003, SB-ACS-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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