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Magnetocardiography as a Noninvasive Diagnostic Strategy for Identifying Coronary Allograft Vasculopathy

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

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.

Eligibility

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 details

Coronary Allograft Vasculopathy (CAV)

NCT05751915

Genetesis Inc.

25 January 2024

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