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

Magnetocardiography as a Noninvasive Diagnostic Strategy for Suspected Myocardial Ischemia With the Absence of Obstructive Coronary Artery Disease As Confirmed by Thermodilution-Derived CFR

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Heart Disease; Coronary Microvascular Disease; Angina
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Zoe E Swann, PhD; Phone Number: 4802868695; Email: zoe.swann@genetesis.com

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
      • Contact: Odayme Quesada, MD, MHS; Phone Number: 513-792-7800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of Myocardial Ischemia in the Absence of Obstructive Coronary Artery Disease (INOCA)	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)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Experiences with MCG		6 months
Participant Demographic Characteristics	weight (kg)	6 months
Participant Demographic Characteristics	age, sex, vital signs	6 months
Electrocardiogram (EKG)	If participants have undergone electrocardiogram (EKG) testing, the results will be considered to provide additional insights into their cardiac electrical activity.	6 months
Invasive Coronary Flow Reserve (CFR) and Angiogram Outcomes		6 months

Collaborators and Investigators

• Sponsor: Genetesis Inc.
• Investigators: Principal Investigator: Odayme E Quesada, MD, The Christ Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 21, 2023
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 17, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: CardioFlux; Magnetocardiography; CFR via Thermodilution
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Angina Pectoris; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Microvascular Angina
• Other Study ID Numbers: MICRO(T)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes