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NCT Number: NCT06481943

A Prospective Research Investigation of Ischemia Using MCG

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sponsor MCG device (CardiAQ)

Device

Unshielded magnetocardiography device for measuring cardiac magnetic fields

Primary outcomes

  1. 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.

Secondary outcomes

  1. Sponsor MCG device safety

    Time frame: 30 days

    Device-related adverse events

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

SB Technology, Inc.

Industry

Collaborators

  • Icahn School of Medicine at Mount Sinai
  • Mayo Clinic

Registry information

Official study title

A Prospective Research Investigation of Ischemia Using SandboxAQ Magnetocardiography Device

Acronym: PRISM/PRISM2

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 1, 2024
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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