MCG for Suspected INOCA Confirmed by Thermodilution-Derived CFR
NCT ID: NCT06139094
Last Updated: 2024-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
48 participants
OBSERVATIONAL
2023-12-20
2024-05-13
Brief Summary
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Detailed Description
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The study utilizes a magnetocardiography (MCG) scanner known as CardioFlux, complemented by cloud processing software. The scanning procedure is designed to last approximately 15 minutes per participant, encompassing 5 minutes for patient preparation, 5 minutes for the CardioFlux scan, and an additional 5 minutes for a post-scan patient survey.
The primary objective is to assess the ability of MCG, through CardioFlux, to accurately determine the presence of myocardial ischemia in comparison to the reference standard CFR. The study will provide valuable insights into the diagnostic potential of MCG and its role in CMD detection, contributing to advancements in non-invasive cardiovascular diagnostics.
The primary study outcome measures shall be the detection of myocardial ischemia with no obstructive coronary artery disease (INOCA) using MCG-CF compared to Cardiac Thermodilution derived CFR. The secondary study outcome measures shall be the MCG Questionnaire, Demographic data (age, sex, height, weight, etc.), Relevant patient medical history, EKG results (if available), and Invasive CFR/angiogram results.
Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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CMD negative
Participants in this group exhibit no signs of Coronary Microvascular Disease (CMD), as evidenced by a CFR measurement equal to or greater than 2.5. This group serves as the comparative reference, representing individuals without CMD-related myocardial ischemia.
CardioFlux Magnetocardiography
The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with a cloud processing software. CardioFlux devices are owned by Genetesis and are currently cleared for the acquisition, display, and analysis of magnetic fields generated by cardiac electrical activity (K182571, FDA clearance letter available for download online)
CMD positive
This group comprises participants demonstrating signs of Coronary Microvascular Disease (CMD), defined by a coronary flow reserve (CFR) measurement of less than 2.5. Participants in this category are experiencing myocardial ischemia without significant blockages in their coronary arteries.
CardioFlux Magnetocardiography
The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with a cloud processing software. CardioFlux devices are owned by Genetesis and are currently cleared for the acquisition, display, and analysis of magnetic fields generated by cardiac electrical activity (K182571, FDA clearance letter available for download online)
Interventions
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CardioFlux Magnetocardiography
The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with a cloud processing software. CardioFlux devices are owned by Genetesis and are currently cleared for the acquisition, display, and analysis of magnetic fields generated by cardiac electrical activity (K182571, FDA clearance letter available for download online)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Genetesis Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Odayme E Quesada, MD
Role: PRINCIPAL_INVESTIGATOR
The Christ Hospital
Locations
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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
Countries
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Other Identifiers
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MICRO(T)
Identifier Type: -
Identifier Source: org_study_id
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