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Magnetocardiography as a Noninvasive Diagnostic Strategy for Identifying Coronary Allograft Vasculopathy

United States40 participantsStarted 2023-05-23

Plain-language 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:

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: 6 months

Trial details

NCT IDNCT05751915

SponsorGenetesis Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12-30

Contact for this trial

Melanie L Gruen, MS

8594684273 melanie.gruen@genetesis.com

View on ClinicalTrials.gov More Coronary Allograft Vasculopathy (CAV) trials