Using magnetocardiography to diagnose coronary allograft vasculopathy
Magnetocardiography as a Noninvasive Diagnostic Strategy for Identifying Coronary Allograft Vasculopathy
This study is testing if a new noninvasive heart scan called magnetocardiography can help doctors better detect coronary allograft vasculopathy in adult heart transplant patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genetesis Inc. Industry-sponsored |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05751915 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of magnetocardiography (MCG) as a noninvasive diagnostic tool for identifying coronary allograft vasculopathy (CAV) in adult heart transplant recipients. It compares MCG results with the current standard of care, which involves cardiac positron emission tomography (PET) scoring. Participants must have undergone a cardiac PET within the last two weeks and meet specific inclusion criteria. The goal is to determine if MCG can serve as a reliable method for regular surveillance of CAV in transplant patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adult heart transplant recipients aged 18 and older who have recently completed a cardiac PET scan.
Not a fit: Patients with implanted ferromagnetic devices or severe claustrophobia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more accessible method for monitoring coronary allograft vasculopathy in heart transplant recipients.
How similar studies have performed: While the use of magnetocardiography is a novel approach, other studies have shown success with noninvasive imaging techniques for cardiac assessments.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- The Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Paul Cremer, MD — The Cleveland Clinic
- Study coordinator: Melanie L Gruen, MS
- Email: melanie.gruen@genetesis.com
- Phone: 8594684273
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.