NCT06481943|RecruitingFDA Device
A Prospective Research Investigation of Ischemia Using MCG
PRISM/PRISM2
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PRISM/PRISM2
Sponsor study identifier
observational
335
1 country
2
Study Start
July 11, 2024
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 25, 2024
Actual (reported)July 1, 2024
Actual (reported)July 11, 2024
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Data taken within 24 hours of each other
Sponsor MCG device safety
30 days
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.
Unshielded magnetocardiography device for measuring cardiac magnetic fields
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Adult patients who are undergoing a diagnostic angiography or revascularization procedure for the diagnosis or treatment of ischemia or acute coronary syndrome (ACS).
Mayo Clinic
Rochester, Minnesota, 55905, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Kit Yee Au-Yeung, PhD
SB Technology, Inc.
First Submitted
June 25, 2024
First Posted
July 1, 2024
Study Start
July 11, 2024
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
AngelMed Guardian® System PMA Post Approval Study
Contact the study team to confirm eligibility.
Study Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 4, 2026
Record last verified: 2025-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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