Comprehensive Cardiac Structure-Function Analysis in Heart Transplantation - Renewal
Trial ID: NCT05521399
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2021-11-19
Completion date: 2030-01-31
Sponsor: Northwestern University
Collaborators: National Institutes of Health (NIH)
Conditions: Transplant, Heart; Magnetic Resonance Imaging
Interventions: MRI Sequencing; MRI Testing (pediatric); MRI Testing
Locations: Northwestern University- Feinberg School of Medicine; The Ann & Robert Lurie Children's Hospital
Countries: United States; United States
Enrollment: 247
Age range: None - None
Sex: ALL

Summary:
Heart transplantation (HTx) is a well-established life-saving procedure but is associated with severe complications. Regular monitoring of heart transplant recipients is thus important for the early detection of these complications. Current standard clinical tests, however, rely on frequent invasive procedures including endomyocardial biopsies (EMB) and catheter angiography (Cath). In addition, these standard tests are limited by sampling error, the diffuse nature of HTx complications, and high health care utilization cost, estimated at \>$150,000 per year per patient in the US. To address these limitations, our group has developed a non-invasive multiparametric cardiac MRI, which can quantify abnormal changes in heart tissue and function. Our efforts during the initial period of this study (NIH funded 2014-2019) have focused on the two major complications of HTx: 1) acute cardiac rejection (ACR), the leading cause of death in the first year after heart transplant; and 2) cardiac allograft vasculopathy (CAV), the greatest risk factor for 5-year mortality beyond the first year after heart transplantation. For these major compilation, our previous cardiac MRI studies have identified new non-invasive cardiac MRI measures that can detect abnormalities of heart tissue and function. In addition, the data was able to show that heart donor and recipient mismatch (age, sex, height, weight, etc.) can cause changes in tissue and function of the transplanted heart.

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.

Outcomes:
Number and severity of acute rejection (ACR) episodes at follow up, quantified by ACR grade (1R, 2R, 3R); Severity of cardiac allograft vasculopathy (CAV) at follow-up, quantified by CAV grade (0,1,2,3)