NCT05751915

Magnetocardiography as a Noninvasive Diagnostic Strategy for Identifying Coronary Allograft Vasculopathy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Genetesis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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:

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.

Conditions

• Coronary Allograft Vasculopathy (CAV)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-23
• Primary completion: 2023-12-30
• Completion: 2024-01-30
• First posted: 2023-03-02
• Last updated: 2023-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study