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Heart transplant monitoring may go needle-free with new MRI technique

NCT ID NCT05521399

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 247 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Northwestern University- Feinberg School of Medicine

    RECRUITING

    Chicago, Illinois, 60611, United States

  • The Ann & Robert Lurie Children's Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

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