Magnetocardiography as a Noninvasive Diagnostic Strategy for Identifying Coronary Allograft Vasculopathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Allograft Vasculopathy (CAV)
- Sponsor
- Genetesis Inc.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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:
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Time Frame: 6 months
Ability of MCG to identify CAV 0 in heart transplant patients as measured by sensitivity, specificity, positive predictive value, and negative predictive value.
Secondary Outcomes
- 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)