Heart Transplantation - Renewal

Launched by NORTHWESTERN UNIVERSITY · Aug 26, 2022

Keywords

ClinConnect Summary

The "Heart Transplantation - Renewal" clinical trial is studying a new, non-invasive method using cardiac MRI (a type of advanced imaging) to monitor heart transplant patients. This method aims to detect serious complications like acute cardiac rejection, which can happen shortly after a transplant, and cardiac allograft vasculopathy, a condition that can develop later and increase the risk of death. Currently, standard tests often require invasive procedures that can be uncomfortable and costly. The goal of this trial is to see if the new MRI technique can provide a safer and more effective way to monitor the health of transplanted hearts.

To participate, individuals must be at least 18 years old and able to understand and agree to the study. The trial is open to adult heart transplant patients who had a cardiac MRI done before April 2017, as well as pediatric heart transplant patients and healthy children without heart conditions who are receiving MRI scans. Participants can expect to undergo MRI scans that help assess the health of their heart without the need for invasive procedures. It's important to note that people with certain kidney issues or metal implants may not be eligible. This trial represents a promising step toward improving care for heart transplant recipients by using less invasive monitoring techniques.

Gender

ALL

Eligibility 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.