Recruiting
PRISM/PRISM2

SandboxAQ Magnetocardiography Device for Myocardial Ischemia Evaluation

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study AimThis study aims to observe how well a new magnetocardiography device can predict heart issues in people with myocardial ischemia compared to traditional methods.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Cardiovascular Diseases
+2

+ Heart Diseases
+ Vascular Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2024
See protocol details

Summary

Principal SponsorSB Technology, Inc.
Study ContactMaggie LeDang
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 11, 2024Actual date on which the first participant was enrolled.

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.

Official TitleA Prospective Research Investigation of Ischemia Using SandboxAQ Magnetocardiography Device 
NCT06481943
Principal SponsorSB Technology, Inc.
Study ContactMaggie LeDang
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
150 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective: These studies use existing medical records or past data.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Myocardial Ischemia
Acute Coronary Syndrome
Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

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 Objectives

Device-related adverse events

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Recruiting
Mayo ClinicRochester, United StatesSee the location
Recruiting
Mount Sinai HospitalNew York, United States
Recruiting
2 Study Centers
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