Clinical Trials

Ongoing Trials
A prospective, multicenter, observational, single-arm trial to validate CardioFlux MCG’s ability to diagnose myocardial ischemia caused by coronary microvascular dysfunction (CMD) in patients with suspected ischemia and confirmed no obstructive coronary artery disease (suspected INOCA) by using diagnostic measures of coronary flow reserve (CFR) via invasive angiography as a reference standard for diagnosis.
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A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.
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Completed Trials
MCG for Suspected INOCA Confirmed by Thermodilution-Derived CFR
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The South Asian Cardiovascular Clinic at The Christ Hospital is asking patients to participate in an ethnically and genetically focused research study. The purpose of this study is to evaluate the use of a completely non-invasive CardioFlux scan technology. This study will also review genetic biomarkers, additional cardiac imaging, and labs to identify coronary artery disease and coronary microvascular dysfunction in patients who are of South Asian descent.
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MCG as a Noninvasive Diagnostic Strategy for Suspected Coronary Microvascular Dysfunction (MICRO)
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.
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The Accelerated CardioFlux Magnetocardiography-based Early Disposition Study (MAGNETO)
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.
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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.
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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.
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Magnetocardiography Using a Novel Analysis System (CardioFlux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients
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).
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Clinical Trial Milestones

A look at CardioFlux MCG's most important clinical registries, trials & milestones.


June 2024

MICRO2, CardioFlux MCG's pivotal for diagnosing CMD, is initiated at Ascension St. John under co-investigator Edouard Daher.

May 2024

The enrollment goal for MICRO(T) is met and the study is closed to gear up for MICRO2.

January 2024

Ascension St. John enrolls its first MICRO (T) patient.

January 2024

The Christ Hospital enrolls its first MICRO (T) patient.

December 2023

The MICRO(T) study is launched at The Christ Hospital under principal investigator Odayme Quesada.

August 2023

Dr. Nathaniel Dittoe of Kettering Health leads the launch of the The MAGNETO-PET Registry as the first site open to enrollment.

June 2023

The Enrollment Goal for the MICRO study is met for the primary objective analysis.

June 2023

The first clinical study subject in the M-CAV trial is enrolled at The Cleveland Clinic.

May 2023

Dr. Paul Cremer launches his pilot clinical trial program, M-CAV, at the Cleveland Clinic.

December 2022

Cleveland Clinic enrolls its first patient.

December 2022

The MICRO study is launched at The Cleveland Clinic, under Principal Investigator Dr. Khaled Ziada.

November 2022

The Principal Investigators join Genetesis in Detroit, Michigan for early exploratory review of interim analysis data in the ACCMED trial.

October 2022

The Enrollment Goal for the ACCMED clinical trial is met for primary endpoint analysis.

August 2022

The MICRO study expands into a multicenter trial under the direction of Dr. Edouard Daher with Ascension St. John's Hospital in Detroit, Michigan.

February 2021

The first clinical trial subject in the ACCMED study is enrolled at Ascension St. John by Dr. Claire Pearson.

May 2021

The ACCMED study expands to include Wake Forest University in Winston-Salem, North Carolina under the direction of Dr. Simon Mahler and Dr. James Stopyra.

January 2021

The ACCMED Study is expanded to include Ascension St. John's Hospital in Detroit, Michigan under the direction of Principal Investigator Dr. Claire Pearson.

December 2021

The first clinical study subject in the MICRO trial is enrolled at The Christ Hospital by Dr. Odayme Quesada in Cincinnati, Ohio.

November 2021

Dr. Odayme Quesada with The Christ Hospital's Heart & Vascular Center partners with Genetesis to launch the MICRO 1.0 Clinical Trial.

October 2021

The ACCMED study expands to include Beaumont Royal Oak Hospital in Detroit, Michigan under the direction of Dr. Carol Clark.

August 2020

The ACCED clinical trial is launched at the Cleveland Clinic under Lead Principal Investigator Dr. Sharon Mace.