Using CardioFlux MCG to diagnose heart issues without invasive procedures

Magnetocardiography as a Noninvasive Diagnostic Strategy for Suspected Myocardial Ischemia With No Obstructive Coronary Artery Disease

This study is testing whether a new noninvasive heart test called CardioFlux can help diagnose heart problems in patients, especially women, who have symptoms but no blocked arteries.

Quick facts

• Study type: Observational
• Enrollment: 135 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Genetesis Inc. (Industry-sponsored)
• Locations: 8 sites (Gainesville, Florida and 7 other locations)
• Trial ID: NCT06212466 on ClinicalTrials.gov

What this trial studies

This observational trial aims to validate the effectiveness of CardioFlux magnetocardiography (MCG) in diagnosing myocardial ischemia due to coronary microvascular dysfunction in patients suspected of having ischemia but with no obstructive coronary artery disease. The study will utilize coronary flow reserve (CFR) measurements from invasive angiography as a reference standard. By employing a noninvasive approach, the trial seeks to address the diagnostic challenges faced by patients, particularly women, with suspected INOCA. The study will assess the diagnostic accuracy of MCG in identifying coronary microvascular disease in a multicenter setting.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who exhibit signs of chest pain and have undergone or are scheduled for a coronary angiogram.

Not a fit: Patients with obstructive coronary artery disease or those unable to undergo the CardioFlux MCG procedure due to medical device implants will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a noninvasive diagnostic tool for patients suffering from ischemic heart disease, improving early detection and management.

How similar studies have performed: Previous studies have shown promise in using magnetocardiography for diagnosing ischemia, indicating potential success for this novel application.

Eligibility criteria

INCLUSION CRITERIA

In order to be eligible to participate in this study, an individual must meet all the following criteria:

1. ≥ 18 years of age at the time of enrollment.
2. Willing to provide written informed consent.
3. Signs and symptoms of chest pain prompted further evaluation by a coronary angiogram within the previous 5 years.
4. Invasive CFR (via bolus thermodilution) completed within 180 days, or scheduled within 30 days, of informed consent.

   4.1. CFR must be performed in the mid Left Anterior Descending (LAD) vessel.
5. Successfully passing CardioFlux MCG Quality Preview prior to MCG study scan. 5.1. Patients must be able to fit into the device. 5.2. Patients must be able to lie supine for 5 minutes. 5.3. Patients must not have any of the following: 5.3.1. Presence of ferromagnetic metal between the sternal notch and costal margin of the rib cage.

5.3.2. Implanted pacemakers or cardioverter/defibrillators. 5.3.3. Implanted infusion pumps and/or neuro stimulators. 5.3.4. Note: sternotomy wires and stents are acceptable. 5.3.5. Note: Failure to meet inclusion criteria 5.3 will render the MCG scan uninterpretable. However, any patient who may be scanned with the presence of any of the above objects is not at any risk of harm by the device. Prosthetic joints are allowed if the MCG Quality Preview is acceptable.

EXCLUSION CRITERIA

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Obstructive CAD (either anatomical or physiological) defined as:

   1.1. ≥ 70% lesion in any major epicardial or branch vessel by CT or invasive Angiography; 1.2. ≥ 50% lesion in the Left Main (LM) vessel by CT or invasive Angiography; 1.3. or either an FFR\<0.80 or iFR or RFR \<0.89 in the obstructed vessel,
2. Any of the following cardiac pathologies:

   2.1. Epicardial spasm. 2.2. History of non-ischemic dilated or hypertrophic cardiomyopathy. 2.3. Suspected myocarditis. 2.4. Documented acute coronary syndrome (ACS) within previous 30 days. 2.5. Known left ventricular ejection fraction (LVEF) \<45% on most recent assessment (can be via ECHO), or hospitalization for Reduced ejection fraction within 180 days. (HFpEF is allowed).

   2.6. Currently in atrial fibrillation or atrial flutter at the time of enrollment.

   2.7. Complete Bundle Branch Block. 2.8. Known moderate or severe valvular disease (anything besides mild). 2.9. Known severe Left ventricular hypertrophy (LVH) as determined by Echocardiography.

   2.10. Dextrocardia.
3. Known estimated glomerular filtration rate (eGFR) \<30 ml/min.
4. Life expectancy \<3-yrs. due to non-cardiovascular comorbidity.
5. Concurrent enrollment in a clinical trial in which therapeutic intervention is administered within 30 days of enrollment.
6. Prior enrollment in MICRO 1.0 and/or MICRO(T) data development study.
7. Pregnancy.

Where this trial is running

Gainesville, Florida and 7 other locations

• University of Florida, Division of Cardiovascular Medicine — Gainesville, Florida, United States (Recruiting)
• Saint Elizabeth Medical Center — Saint Elizabeth Medical Center, Kentucky, United States (Recruiting)
• Ascension St. John Hospital — Detroit, Michigan, United States (Completed)
• Mayo Clinic, Cardiovascular Research — Rochester, Minnesota, United States (Recruiting)
• St. Luke's Health System, Cardiovascular Research — Kansas City, Missouri, United States (Recruiting)
• Hackensack Meridian Mountainside Medical Center — Montclair, New Jersey, United States (Recruiting)
• The Christ Hospital — Cincinnati, Ohio, United States (Recruiting)
• Cleveland Clinic, Cardiovascular Medicine Research — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Zoe E Swann, PhD

Conditions Ischemic Heart Disease; Coronary Microvascular Disease; Angina; Myocardial Ischemia; Magnetocardiography; CardioFlux; Coronary Flow Reserve