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Magnetocardiography as a Noninvasive Diagnostic Strategy for Identifying Coronary Allograft Vasculopathy

NCT05751915 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-07-11

No results posted yet for this study

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:

Conditions

  • Coronary Allograft Vasculopathy (CAV)

Interventions

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.

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Genetesis Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Cremer, MD · The Cleveland Clinic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2023-12-30
Completion
2024-01-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05751915 on ClinicalTrials.gov