Magnetocardiography as a Noninvasive Diagnostic Strategy for Identifying Coronary Allograft Vasculopathy (M-CAV)

Purpose: To show early feasibility of magnetocardiography (MCG) to identify coronary Cardiac positron emission tomography (PET) is the preferred non-invasive tests to assess for CAV and incorporation of quantitative myocardial blood flow (MBF) assessment improves diagnostic accuracy. Based on ISHLT criteria, the following have been proposed for diagnosis of CAV by PET:

Study Overview

• Status: Recruiting
• Conditions: Coronary Allograft Vasculopathy (CAV)
• Intervention / Treatment: Device: CardioFlux

Detailed Description

Diagnosing CAV by PET with quantitative myocardial blood flow (MBF) 3 PET CAV 0: Normal perfusion with normal global stress (> 1.7 mL/min/g)

PET CAV 1: Normal perfusion with abnormal global stress MBF (<1.7 mL/min/g and ejection fraction >45%) OR Single vessel perfusion defect with normal global stress MBF.

PET CAV 2/3: Normal perfusion with abnormal global stress MBF (<1.7 mL/min/g) and ejection fraction < 45% OR Single vessel perfusion defect with abnormal global stress MBF (<1.7 mL/min/g) OR Multivessel perfusion defects

With these diagnostic criteria, PET CAV 0 has been shown to have a high negative predictive value for moderate to severe CAV by invasive coronary angiography, and PET CAV 2/3 has been shown to have a high positive predictive value for moderate to severe CAV and is associated with adverse events.

This study further examines the feasibility of MCG in identifying CAV in adult heart transplant recipients and compares those results to the current non-invasive standard using PET CAV scores. This will help determine whether MCG is a potential test for regular surveillance of CAV in transplant recipients.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Melanie L Gruen, MS; Phone Number: 8594684273; Email: melanie.gruen@genetesis.com

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • The Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Heart transplant recipients are susceptible to developing coronary allograft vasculopathy (CAV), a disease that causes blockages in the arteries of the transplanted heart. CAV often progresses without symptoms, and transplant recipients undergo regular surveillance to detect CAV. Current tests used to detect CAV, such as invasive coronary angiography (ICA) and intravascular ultrasound (US) have clear limitations; in addition to being invasive with risk of complications, they are also expensive, time consuming, and require iodinated contrast, a concern in a population with high rates of kidney dysfunction. In addition, these tests may not be able to detect CAV in its early stages. Additionally, the diagnosis of CAV remains a challenge as angiography, the standard method for detecting focal plaques, lacks sensitivity in detecting CAV, and intravascular ultrasonography, a more sensitive method, lacks the ability to evaluate the entirety of the coronary arteries.

Description

Inclusion Criteria:

• ≥ 18 years of age at the time of enrollment

Willing to provide written informed consent

Completed cardiac PET within the last 2 weeks

No changes to medication or intervention since the PET was completed

Exclusion Criteria:

• Patients unable to fit into device

Patients unable to lie supine for 5 minutes

Patients with implanted ferromagnetic objects above the costal margin of the rib cage (implanted pacemakers, cardioverter/defibrillators, infusion pumps, and/or neuro stimulators).

NOTE: Sternotomy wires stents are acceptable

Implanted pacemakers or cardioverter/defibrillators

Implanted infusion pumps and/or neuro stimulators

Severe claustrophobia

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PET CAV 0; Normal perfusion with normal global stress (> 1.7 mL/min/g)	Device: CardioFlux; CardioFlux MCG is a process that observes incremental changes in the heart's electrical activity by the magnetic fields generated by these currents. These magnetic fields have been used for decades via electrocardiogram to help diagnose and treat both acute and chronic cardiac pathology. The CardioFlux device reaches the potential of this phenomenon by sensing a complete magnetic field map. It is equipped with a magnetic shielding chamber and can attenuate magnetic field noise by a factor of nearly 1500 which maximizes signal to noise ratio. CardioFlux is an easy to operate, noninvasive modality that can detect the presence of ischemic cardiac tissue in symptomatic patients in a less than 5-minute scan. The device uses the proprietary software called Faraday which processes MCG scans, create diagnostic functional images, and run analytics.
PET CAV 1; Normal perfusion with abnormal global stress MBF (<1.7 mL/min/g and ejection fraction >45%) OR Single vessel perfusion defect with normal global stress MBF.	Device: CardioFlux; CardioFlux MCG is a process that observes incremental changes in the heart's electrical activity by the magnetic fields generated by these currents. These magnetic fields have been used for decades via electrocardiogram to help diagnose and treat both acute and chronic cardiac pathology. The CardioFlux device reaches the potential of this phenomenon by sensing a complete magnetic field map. It is equipped with a magnetic shielding chamber and can attenuate magnetic field noise by a factor of nearly 1500 which maximizes signal to noise ratio. CardioFlux is an easy to operate, noninvasive modality that can detect the presence of ischemic cardiac tissue in symptomatic patients in a less than 5-minute scan. The device uses the proprietary software called Faraday which processes MCG scans, create diagnostic functional images, and run analytics.
PET CAV 2/3; Normal perfusion with abnormal global stress MBF (<1.7 mL/min/g) and ejection fraction < 45% OR Single vessel perfusion defect with abnormal global stress MBF (<1.7 mL/min/g) OR Multivessel perfusion defects v	Device: CardioFlux; CardioFlux MCG is a process that observes incremental changes in the heart's electrical activity by the magnetic fields generated by these currents. These magnetic fields have been used for decades via electrocardiogram to help diagnose and treat both acute and chronic cardiac pathology. The CardioFlux device reaches the potential of this phenomenon by sensing a complete magnetic field map. It is equipped with a magnetic shielding chamber and can attenuate magnetic field noise by a factor of nearly 1500 which maximizes signal to noise ratio. CardioFlux is an easy to operate, noninvasive modality that can detect the presence of ischemic cardiac tissue in symptomatic patients in a less than 5-minute scan. The device uses the proprietary software called Faraday which processes MCG scans, create diagnostic functional images, and run analytics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the performance (diagnostic capabilities) of magnetocardiography in the diagnosis of coronary vasculopathy (CAV) as compared to PET as the currently accepted gold standard non-invasive tool.	Ability of MCG to identify CAV 0 in heart transplant patients as measured by sensitivity, specificity, positive predictive value, and negative predictive value.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine whether MCG is able to differentiate between CAV 0, 1, and 2/3, and to correlate with absolute stress myocardial blood flow, global CFR (Coronary flow reserve), and LVEF (Left ventricular ejection fraction), as measured by cardiac PET	Differentiation between CAV 0, 1, and 2/3 Correlation of MCG with absolute stress myocardial blood flow Correlation of MCG with global CFR Correlation of MCG with LVEF	6 months

Collaborators and Investigators

• Sponsor: Genetesis Inc.
• Collaborators: The Cleveland Clinic
• Investigators: Principal Investigator: Paul Cremer, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Magnetocardiography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: 10007

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
• product manufactured in and exported from the U.S.: No