Non-invasive monitoring of heart transplant recipients using MRI
Comprehensive Cardiac Structure-Function Analysis in Heart Transplantation - Renewal
This study is testing a new way to monitor heart transplant patients using MRI and artificial intelligence to see if it can help spot problems like rejection and improve their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 247 (estimated) |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT05521399 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include pediatric heart transplant patients undergoing routine cardiac MRI for graft surveillance.
Not a fit: Patients with abnormal kidney function or those who have had a kidney and/or liver transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for invasive procedures and improve early detection of complications in heart transplant recipients.
How similar studies have performed: Other studies have shown promise in using non-invasive imaging techniques for monitoring transplant patients, but this specific approach utilizing AI in cardiac MRI is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.