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MCG for Suspected INOCA Confirmed by Thermodilution-Derived CFR (MICRO(T))

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ClinicalTrials.gov Identifier: NCT06139094
Recruitment Status : Recruiting
First Posted : November 18, 2023
Last Update Posted : January 5, 2024
Sponsor:
Information provided by (Responsible Party):
Genetesis Inc.

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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. Up to 200 participants in a 1:1 ratio of CMD positive to CMD negative will be enrolled. 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.

Condition or disease Intervention/treatment
Ischemic Heart Disease Coronary Microvascular Disease Angina Device: CardioFlux Magnetocardiography

Detailed Description:

This observational registry study focuses on investigating the efficacy of magnetocardiography (MCG) in detecting myocardial ischemia in the absence of obstructive coronary artery disease (CMD). The reference standard for diagnosis will be invasive coronary flow reserve (CFR) measured using thermodilution. The study aims to enroll up to 200 participants in a 1:1 ratio of CMD positive to CMD negative cases.

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 1 Day
Official Title: Magnetocardiography as a Noninvasive Diagnostic Strategy for Suspected Myocardial Ischemia With the Absence of Obstructive Coronary Artery Disease As Confirmed by Thermodilution-Derived CFR
Actual Study Start Date : December 20, 2023
Estimated Primary Completion Date : February 28, 2024
Estimated Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Device: 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.
 Device: 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)


Outcome Measures
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Primary Outcome Measures :
  1. Detection of Myocardial Ischemia in the Absence of Obstructive Coronary Artery Disease (INOCA) [ Time Frame: 6 months ]
    The primary focus of the study is to assess the efficacy of magnetocardiography with CardioFlux (MCG-CF) in detecting myocardial ischemia in individuals with no obstructive coronary artery disease (INOCA). The comparison will be made against Cardiac Thermodilution-derived Coronary Flow Reserve (CFR)


Secondary Outcome Measures :
  1. Patient-Reported Experiences with MCG [ Time Frame: 6 months ]
  2. Participant Demographic Characteristics [ Time Frame: 6 months ]
    weight (kg)

  3. Participant Demographic Characteristics [ Time Frame: 6 months ]
    age, sex, vital signs

  4. Electrocardiogram (EKG) [ Time Frame: 6 months ]
    If participants have undergone electrocardiogram (EKG) testing, the results will be considered to provide additional insights into their cardiac electrical activity.

  5. Invasive Coronary Flow Reserve (CFR) and Angiogram Outcomes [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men and women with suspected or confirmed myocardial ischemia with no obstructive coronary artery disease (INOCA).
Criteria

Inclusion Criteria:

  • ≥ 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06139094


Contacts
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Contact: Zoe E Swann, PhD 4802868695 zoe.swann@genetesis.com

Locations
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United States, Michigan
Ascension St. John Hospital Not yet recruiting
Detroit, Michigan, United States, 48236
Contact: Edouard Daher, MD         
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Odayme Quesada, MD, MHS    513-792-7800      
Sponsors and Collaborators
Genetesis Inc.
Investigators
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Principal Investigator: Odayme E Quesada, MD The Christ Hospital
More Information
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Responsible Party: Genetesis Inc.
ClinicalTrials.gov Identifier: NCT06139094    
Other Study ID Numbers: MICRO(T)
First Posted: November 18, 2023    Key Record Dates
Last Update Posted: January 5, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Genetesis Inc.:
Magnetocardiography
CFR via Thermodilution
CardioFlux
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Microvascular Angina
Cardiovascular Diseases
 Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Angina Pectoris