Magnetocardiography as a Noninvasive Diagnostic Strategy for Identifying Coronary Allograft Vasculopathy

NCT05751915 | Unknown FDA Device

• 1 other identifier: 10007
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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:

Conditions

Coronary Allograft Vasculopathy (CAV)

Keywords

Magnetocardiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

PET CAV 0

Normal perfusion with normal global stress (\> 1.7 mL/min/g)

Device: CardioFlux

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

Interventions

CardioFlux DEVICE

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 0; PET CAV 1; PET CAV 2/3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genetesis Inc.: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Study Officials

• Paul Cremer, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie L Gruen, MS

CONTACT

8594684273; melanie.gruen@genetesis.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 2, 2023
• Study Start: May 23, 2023
• Primary Completion: December 30, 2023
• Study Completion: January 30, 2024
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)