This is a single center observational trial in partnership with The Christ Hospital (Cincinnati, OH). The purpose of this study is to investigate MCG’s ability to identify coronary microvascular dysfunction in patients with ischemia and no obstructive coronary artery disease (INOCA). The primary endpoint is the diagnostic accuracy of MCG in determining the presence of INOCA and/or coronary microvascular dysfunction, by using gold standard coronary reactivity testing (CRT) as the reference.
The Accelerated CardioFlux Magnetocardiography-based Early Disposition Study (ACCMED)
This trial is a 400 patient multicenter, prospective, observational cohort trial to compare the predicted outcome of suspected Acute Coronary Syndrome patients, in the Emergency Room setting, using a CardioFlux directed diagnostic pathway versus the actual patient outcome in the study cohort using the standard of care diagnostic pathway.
Magnetocardiography Using a Novel Analysis System (CardioFlux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients
Genetesis is a cardiac diagnostics company which presents a novel magnetocardiogram (MCG) analysis system called CardioFlux. This investigation presents a new, noninvasive diagnostic option to use MCG for rapid diagnosis of acute coronary syndrome. Data from the CardioFlux system was compared with stress testing methods as well as the results of cardiac catheterization to identify patients with myocardial ischemia.
This was a prospective observational single-blinded convenience pilot study of 101 patients placed in the Clinical Decision Unit (CDU) for evaluation of chest pain at St. John Hospital and Medical Center (Detroit, MI).
Patients enrolled in the study also had a 30 and 180 day follow up for analysis of adverse cardiac events.
Role of CardioFlux in Predicting Coronary Artery Disease (CAD) Outcomes
This single-center clinical trial is designed to evaluate the CardioFlux magnetocardiograph diagnostic imaging system to predict major adverse cardiac events (MACE) in patients referred to outpatient evaluation for coronary artery disease.
Use of Magnetocardiography in Evaluation of Patients Going for Cardiac Catheterization
This is a multicenter, prospective trial to measure the test performance characterisitics of the Magnetocardiography (MCG) CardioFlux cardiac diagnostic system in detecting clinically significant coronary atrery obstruction in patients with symptoms of suspected acute coronary syndrome or who present with a failed stress test with the intention to treat with cardiac catheterization.