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Observational Study: Improving Heart Transplant Monitoring with MRI

This observational study is looking at new ways to monitor children and adults who have received heart transplants. The researchers are testing advanced MRI (Magnetic Resonance Imaging) techniques to better detect complications like acute rejection (ACR) and cardiac allograft vasculopathy (CAV) – problems that can happen after a transplant. They hope these MRI tests can provide a less invasive and more accurate way to check on the transplanted heart compared to current methods. The study will also use artificial intelligence to help analyze the MRI results more efficiently. The goal is to improve how doctors monitor heart transplant patients and predict outcomes. The study plans to include 247 participants, but its current status is unclear.

Study design
This is an observational study, meaning researchers will be watching and collecting information. It aims to enroll 247 participants, including both adults and children.
What's involved
Participants will undergo cardiac MRI testing. For some, this will involve an MRI test-retest for developing new MRI sequences.
Compensation
Not stated in the trial record.
Follow-up
The study will track the number and severity of acute rejection episodes and cardiac allograft vasculopathy for up to 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05521399

Heart Transplantation - Renewal

Recruiting
Not specifiedAll AgesObservational
Northwestern University
~247 participants
Updated 2026-03-24 on ClinicalTrials.gov
What's tested:MRI SequencingMRI Testing (pediatric)MRI Testing

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and severity of acute rejection (ACR) episodes at follow up, quantified by ACR grade (1R, 2R, 3R)
Measured over 4 years
+1 more outcome measured

Conditions

Transplant, Heart
Magnetic Resonance Imaging

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NCT05521399

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Northwestern University- Feinberg School of Medicine

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • The Ann & Robert Lurie Children's Hospital

    Chicago, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Emily Powell
[email protected]
3126952956
Email the study team

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Eligibility criteria

Inclusion

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
Baseline cardiac MRI prior to 4/2017
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.
All ages
Receiving baseline clinical cardiac MRI
Past heart Tx

Exclusion

Contraindication to MRI i.e. device implants, metal hardware, etc as determined by staff technologists
Adults unable to consent
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.

What this trial measures

  • Number and severity of acute rejection (ACR) episodes at follow up, quantified by ACR grade (1R, 2R, 3R)4 years

    Long-term Follow-Up (\> 5 years) will determine the prognostic value for cardiac MRI metrics (T2, T1, LV, and RV volumes, cardiac strain, myocardial fibrosis) for graft complications as defined by the number of acute rejection (ACR) episodes, ACR grade (1R, 2R, 3R)

  • Severity of cardiac allograft vasculopathy (CAV) at follow-up, quantified by CAV grade (0,1,2,3)4 years

    Long-term Follow-Up (\> 5 years) will determine the prognostic value for cardiac MRI metrics (T2, T1, LV, and RV volumes, cardiac strain, myocardial fibrosis) for graft complications as defined by ardiac allograft vasculopathy (CAV) grade (0,1,2)