Comprehensive Cardiac Structure-Function Analysis in Heart Transplantation - Renewal

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

‣ 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

Locations
United States
Illinois
Northwestern University- Feinberg School of Medicine
RECRUITING
Chicago
The Ann & Robert Lurie Children's Hospital
RECRUITING
Chicago
Contact Information
Primary
Emily Powell
emily.powell@northwestern.edu
3126952956
Backup
Ayesha Muzaffar
ayesha.muzaffar@northwestern.edu
312-926-4251
Time Frame
Start Date: 2021-11-19
Estimated Completion Date: 2030-01-31
Participants
Target number of participants: 247
Treatments
Aim#1 Development
Developing dedicated multiparametric cardiac MRI protocols that account for a wide range of body sizes and patient physiology (e.g., heart rates, breathing patterns) of heart transplant recipients, is critical for the wide age range in HTx from pediatric to adult. Second, to facilitate clinical translation and multi-site portability of the often time-consuming data analysis. Methodology, to be employed and developed artificial intelligence (AI) deep learning concepts to enable automated cardiac MRI analysis across large cohorts. The hypothesis to be tested is that automated AI analysis can detect altered cardiac MRI metrics with improved efficiency and reduced inter-rater variability
Aim#2 Cardiac MRI in Pediatric HTx & Donor-Recipient Mismatch
Comprehensive cardiac MRI measures will be evaluated for the identification of complications after heart transplantation (ACR, CAV) in children. The anticipated enrollment of n=80 (20 per year) pediatric HTx patients (\<21 years) in years 2-5 at Lurie Children's Hospital. Inclusion criteria include a clinically indicated routine cardiac MRI for HTx graft surveillance. The hypothesis to be tested is that cardiac MRI measures can inform pediatric donor selection by providing important new data on the impact of donor-recipient mismatch (e.g. age, sex, heart size, etc.) on changes in tissue and function of the transplanted heart.
Aim#3 Longitudinal patient outcome study
The study will research the diagnostic value of cardiac MRI to improve the monitoring of heart transplant recipients for the major complications of acute cardiac rejection (ACR) and cardiac allograft vasculopathy (CAV). The anticipated follow-up enrollment of a total of 80 HTx patients during years 2-5 with a minimum of 5-year follow-up (20 HTx patients/year returning for HTx surveillance, baseline MRI scan was performed during the initial funding period. To clarify, our aim isn't to perfectly match donor-recipient but rather to study the clinical implications of mismatch and to help define the threshold for too much mismatch. In other words, today human beings sometimes don't accept a heart if the mismatch will be too great, this is sometimes hard to do and literature is scarce, especially in terms of functional rather than anatomic implications. Our goal is that this study could better inform these decisions.
Related Therapeutic Areas
Sponsors
Collaborators: National Institutes of Health (NIH)
Leads: Northwestern University

This content was sourced from clinicaltrials.gov