Heart transplant monitoring may go needle-free with new MRI technique
NCT ID NCT05521399
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study explores whether a special cardiac MRI can detect complications after heart transplantation without the need for invasive biopsies or angiography. Researchers will scan 247 adults and children, including healthy volunteers and transplant recipients, to see if MRI measures of heart tissue and function can predict rejection and blood vessel damage. If it works, it could make monitoring safer, cheaper, and more comfortable for patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cardiac MRI (diagnostic test)
- What this could lead to
- If successful, this could replace painful, risky biopsies and angiograms with a simple, non-invasive MRI scan for heart transplant patients.
- What could go wrong
- This is an observational study, not a treatment trial. The MRI technique is still being refined, and it may not be accurate enough to fully replace current invasive tests.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 247 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2021
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population includes pediatric and non-pediatric healthy volunteers; as well as, non-pediatric and pediatric heart transplant patients.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Northwestern University- Feinberg School of Medicine
RECRUITINGChicago, Illinois, 60611, United States
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The Ann & Robert Lurie Children's Hospital
RECRUITINGChicago, Illinois, 60611, United States
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