MCG for Suspected INOCA Confirmed by Thermodilution-Derived CFR

Completed

Conditions studied: Ischemic Heart Disease, Coronary Microvascular Disease, Angina

In brief

This study will be an observational registry to investigate the ability of magnetocardiography (MCG) in determining the presence of myocardial ischemia with the absence of obstructive coronary artery disease, by using an invasive reference standard coronary flow reserve (CFR) measured using thermodilution for diagnosis. The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with cloud processing software. A CardioFlux scan appointment shall last approximately 15 minutes in duration and include a patient questionnaire following the scan.

Key facts

Study ID

NCT06139094

Run by

Genetesis Inc.

People needed

48

Starts

2023-12-20

Expected to finish

2024-05-13

Last updated by the study team

2024-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years of age at the time of enrollment.
• Signs and symptoms of coronary ischemia that prompted further evaluation by either invasive coronary angiography or coronary CT angiogram) within the previous 5 years.
• Willing to provide written informed consent.
• Non-obstructive CAD defined as: 0 to 49% diameter reduction of a major epicardial vessel or FFR>0.80 (or non-hyperemic equivalent of iFR or RFR >0.89)
• Completed invasive CFR via thermodilution method within 6 months of informed consent.
• Successfully passing CardioFlux's MCG ""Quality Preview" prior to MCG study scan.

You may not qualify if…

• Patients unable to fit into the CardioFlux device.
• Patients who meet device contraindications (as specified in section 1.4 of the protocol) NOTE: Sternotomy wires and stents are typically acceptable.
• Patients unable to lie supine for 5 minutes.
• History of non-ischemic dilated or hypertrophic cardiomyopathy.
• Documented acute coronary syndrome (ACS) within the previous 30 days.
• Known left ventricular ejection fraction (LVEF) <45%, or hospitalization for Reduced ejection fraction within 180 days. (HFpEF is permitted).
• Currently in atrial fibrillation or atrial flutter at the time of enrollment.
• Estimated glomerular filtration rate (eGFR) <30 ml/min.
• Moderate or severe valvular disease (including aortic stenosis or insufficiency).
• Life expectancy <1-yrs. due to non-cardiovascular comorbidity.
• Concurrent enrollment in a clinical trial in which therapeutic intervention is administered within 30 days of enrollment.
• Pregnancy.
• Dextrocardia.
• History of Left or Right Bundle Branch Block within 6 months of enrollment.

Where it is running

• University of Florida — Gainesville, Florida, United States
• Ascension St. John Hospital — Detroit, Michigan, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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