RECRUITING

Heart Transplantation - Renewal

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Comprehensive Cardiac Structure-Function Analysis in Heart Transplantation - Renewal

Quick Facts

Study Start:2021-11-19
Study Completion:2030-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05521399

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years of age
  2. * Able to complete the MR safety screening form as required by SOC
  3. * Able to comprehend and provide informed consent
  4. * All ages
  5. * No known CHD
  6. * 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.
  7. * All ages
  8. * Receiving baseline clinical cardiac MRI
  9. * Past heart Tx
  1. * 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
  2. * Contraindication to MRI i.e. device implants, metal hardware, etc as determined by staff technologists
  3. * Adults unable to consent
  4. * Patients who have not received a heart transplant
  5. * Patients who have not received a cardiac MRI at baseline
  6. * Individuals not receiving the supplemental 10-minute scan, due to GA concerns, will be counted towards the desired study population.
  7. * 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.

Contacts and Locations

Study Contact

Emily Powell
CONTACT
3126952956
emily.powell@northwestern.edu
Ayesha Muzaffar
CONTACT
312-926-4251
ayesha.muzaffar@northwestern.edu

Study Locations (Sites)

Northwestern University- Feinberg School of Medicine
Chicago, Illinois, 60611
United States
The Ann & Robert Lurie Children's Hospital
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-19
Study Completion Date2030-01-31

Study Record Updates

Study Start Date2021-11-19
Study Completion Date2030-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Transplant, Heart
  • Magnetic Resonance Imaging