An observational study in Coronary Allograft Vasculopathy (CAV), sponsored by Genetesis Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-11.
Sponsored by Genetesis Inc. · Observational
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:
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.
Genetesis Inc. is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Willing to provide written
Completed cardiac PET within the last 2 weeks
No changes to medication or intervention since the PET was completed
Exclusion Criteria:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Normal perfusion with normal global stress (\> 1.7 mL/min/g)
Device: CardioFlux
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
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.
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.
Time frame: 6 months
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
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
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Dec 2023, 7 months after the start.
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Genetesis Inc.