CardiAQ MCG Device for Acute Coronary Syndrome
(PRISM/PRISM2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called CardiAQ MCG to determine if it can help doctors better understand heart issues like ischemia (reduced blood flow to the heart) and heart attacks. The device operates at the bedside, potentially making heart problem diagnosis quicker and easier. Participants should be adults scheduled for heart procedures such as angiography or revascularization to treat or diagnose heart conditions. This study could lead to faster, more accurate diagnoses for those with heart-related health issues. As a Phase 2 trial, the research measures the device's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in heart health diagnostics.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the CardiAQ MCG device is safe for evaluating myocardial ischemia and infarction?
Research has shown that the CardiAQ magnetocardiography (MCG) device has undergone testing to ensure safety and effectiveness. MCG is a non-invasive tool, meaning it does not require insertion into the body, which generally makes it safe and easy to tolerate. Past research has used MCG to detect heart problems such as coronary artery disease. So far, no reports of harmful effects have emerged from using the device. As the CardiAQ MCG undergoes testing in a pilot study, safety checks continue, but its non-invasive nature suggests it should be safe for most people.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it uses Magnetocardiography (MCG), a non-invasive technique, to study ischemia and acute coronary syndrome (ACS). Unlike traditional methods like angiography, which are invasive and involve the use of contrast dyes, MCG measures the magnetic fields produced by the heart's electrical activity, offering a safer and more patient-friendly alternative. This technique promises to provide detailed insights into heart health without the risks associated with invasive procedures, potentially transforming how these conditions are diagnosed and managed.
What evidence suggests that the CardiAQ MCG device is effective for evaluating myocardial ischemia and infarction?
Research has shown that magnetocardiography (MCG), like the CardiAQ device studied in this trial, effectively detects heart problems such as myocardial ischemia, which occurs when the heart receives insufficient blood. Studies have found that MCG can identify serious blockages in heart arteries, potentially leading to heart attacks. In some studies, MCG successfully identified patients with major artery problems, even when other tests faced challenges. The device can help predict major heart issues within 30 to 180 days after certain heart procedures. Overall, MCG appears to be a promising tool for early and effective detection of heart problems.12678
Who Is on the Research Team?
Kit Yee Au-Yeung, PhD
Principal Investigator
SB Technology, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo diagnostic angiography or revascularization procedure and are evaluated using the CardiAQ MCG device
Follow-up
Participants are monitored for device-related adverse events and the relationship between MCG and angiography-based measures
What Are the Treatments Tested in This Trial?
Interventions
- Sponsor MCG device (CardiAQ)
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SB Technology, Inc.
Lead Sponsor
Mayo Clinic
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
Citations
1.
trialx.com
trialx.com/clinical-trials/listings/323159/a-prospective-research-investigation-of-ischemia-using-mcg/A Prospective Research Investigation of Ischemia Using ...
PRISM is a prospective, pilot research study that aims to systematically characterize the usefulness of CardiAQ MCG, a bedside ...
Accelerated magnetocardiography in the evaluation of ...
MCGs were read independently by 3 physicians blinded to clinical data. Myocardial ischemia was ≥70 % epicardial coronary artery stenosis, ...
Use of Magnetocardiography in Evaluation of Patients ...
These results will be used to determine the value of post-PCI MCG to predict 30 day and 180 day major adverse cardiac events (MACE)-specifically myocardial ...
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Acute Coronary Syndrome CardioFlux TM Study (ACCMED)
The purpose of ACCMED is to measure the efficacy of Magnetocardiography (MCG) as a diagnostic tool to rule-in/rule-out myocardial ischemia in patients with ...
MCG for Identification of Myocardial Ischemia in Suspected ...
The aim of this observational study is to optimize and validate MCG models as a fast and accurate strategy for detecting coronary ischemia, as a shortage of ...
NCT05825911 | Evaluation of Diagnostic Accuracy of MCG ...
This multicenter clinical trial is designed to evaluate the diagnostic accuracy of MCG scan in detecting significant CAD compared to the reference standard CAG.
VitalScan MCG Rule-out Multi-centre Pivotal Study - UK
The study is a prospective multi-centre observational study to evaluate a portable magnetocardiograph device for the rule-out of acute coronary syndrome ...
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