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

Sponsor

Genetesis Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05751915

Collaborator

The Cleveland Clinic (Other)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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:

Condition or Disease	Intervention/Treatment	Phase
Coronary Allograft Vasculopathy (CAV)	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Magnetocardiography as a Noninvasive Diagnostic Strategy for Identifying Coronary Allograft Vasculopathy

Anticipated Study Start Date :

Feb 28, 2023

Anticipated Primary Completion Date :

Aug 30, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

Arm	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.

Arm

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

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

Outcome Measures

Primary Outcome Measures

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. [6 months]
Ability of MCG to identify CAV 0 in heart transplant patients as measured by sensitivity, specificity, positive predictive value, and negative predictive value.

Secondary Outcome Measures

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 [6 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Genetesis Inc.
The Cleveland Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Genetesis Inc.

ClinicalTrials.gov Identifier:

NCT05751915

Other Study ID Numbers:

10007

First Posted:

Mar 2, 2023

Last Update Posted:

Mar 2, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Genetesis Inc.

Magnetocardiography

Additional relevant MeSH terms:

Vascular Diseases

Study Results

No Results Posted as of Mar 2, 2023