Non-invasive monitoring of heart transplant recipients using MRI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on improving the monitoring of heart transplant recipients through the development of non-invasive multiparametric cardiac MRI protocols. It aims to address the limitations of current invasive procedures by utilizing artificial intelligence for automated analysis of cardiac MRI data. The study will evaluate the effectiveness of these MRI measures in identifying complications such as acute cardiac rejection and cardiac allograft vasculopathy in pediatric heart transplant patients. The research will involve a cohort of 80 pediatric patients over a five-year period, with the goal of enhancing donor-recipient matching and improving patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

At Northwestern University:

* At least 18 years of age
* Able to complete the MR safety screening form as required by SOC
* Able to comprehend and provide informed consent

Adult Heart Transplant patients scanned at CTI

-Baseline cardiac MRI prior to 4/2017

Pediatric controls scanned at Lurie

* All ages
* No known CHD
* Receiving clinical cardiac MRI: Some pediatric patients are scheduled to receive cardiac -MRI's to rule out congenital heart disease. In some instances, the outcome is normal - these patients would be considered healthy controls. Pediatric controls are getting MRI scans of heart only.

Pediatric heart transplant patients scanned at Lurie

* All ages
* Receiving baseline clinical cardiac MRI
* Past heart Tx

Exclusion Criteria:

* Abnormal kidney function (eGFR \< 30 mL/min/). Patients with a history of kidney problems (GFR \< 30 ml/min) or have had a kidney and/or liver transplant will be excluded from the study or may undergo the MRI exam without the use of a contrast agent, per standard MR exclusion criteria
* Contraindication to MRI i.e. device implants, metal hardware, etc as determined by staff technologists
* Adults unable to consent

Pediatric heart transplant patients scanned at Lurie

* Patients who have not received a heart transplant
* Patients who have not received a cardiac MRI at baseline
* Individuals not receiving the supplemental 10-minute scan, due to GA concerns, will be counted towards the desired study population.
* If a scan returns with an abnormality, they would no longer be considered control and would not be counted towards the desired study population. It is not until the exam is completed the data may be able to determine whether a patient will qualify as a control. Ordering providers routinely order MRI exams to rule out a certain abnormality. This is similar to ordering providers to request a brain MRI if a patient presents with certain symptoms, such as a headache, to rule out a brain tumor. In many cases those exams may return unremarkable.

Where it's running

• Northwestern University- Feinberg School of Medicine
  Chicago, Illinois, United States Recruiting
• The Ann & Robert Lurie Children's Hospital
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Emily Powell
• Email: emily.powell@northwestern.edu
• Phone: 3126952956

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.