RECRUITING

MRI to Predict Rejection and Failure in Transplant and Cardiomyopathy Patients

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

Overall Research Strategy of this protocol is to refine and validate noninvasive CMR imaging sequences with invasive hemodynamic and pathology results to create a comprehensive, noninvasive, radiation-reduced regimen for pediatric cardiomyopathy and cardiac transplant assessment. We were the first to perform MR-guided cardiac catheterization in US children, and have accumulated the largest US experience, having performed over 75 procedures to date. Our unique experience puts us in strong position to leverage this technology to improve care of children with cardiomyopathy and transplant. Using an integrated approach, we will simultaneously (1) validate imaging measures of cardiac edema and fibrosis by correlating T1 and T2 map images with endomyocardial biopsy (EMB) results in Aim 1; (2) overlay T1, T2 map images into our x-ray system to display "hotspots" of T1 and T2 abnormalities to guide EMB in Aim 2; and (3) obtain radiation-free hemodynamic data in a highly vulnerable pediatric population by using CMR to guide catheter manipulation in the ICMR suite in Aim 3. Age and diagnosis-matched historical controls will be identified from the last 10 years at Children's National as a control population for specific purposes of comparing (1) EMB yield without image overlay and (2) Radiation exposure during X-ray guided right heart catheterization. Identical information will be obtained and stored in the same 45CFR compliant database. Historical controls will be identified from the cardiac catheterization database by searching for age and diagnosis. A waiver of consent will be applicable here, as it would be inconvenient, insensitive and not feasible to consent families who have already undergone treatment.

Official Title

Cardiac MRI Increases Accuracy and Decreases Risk of Evaluation of Children with Cardiomyopathy and Cardiac Transplantation

Quick Facts

Study Start:2019-12-10
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03822442

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:6 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Children and adults of any age with heart transplant, suspected or confirmed cardiomyopathy
  2. * Undergoing clinically-indicated ("medically necessary") cardiovascular catheterization
  1. * Cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support.
  2. * Women who are pregnant
  3. * Women who are nursing and who do not plan to discard breast milk for 24 hours
  4. * Exclusion criteria for MRI
  5. * Central nervous system aneurysm clips
  6. * Implanted neural stimulator
  7. * Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
  8. * Cochlear implant
  9. * Ocular foreign body (e.g. metal shavings)
  10. * Implanted Insulin pump
  11. * Metal shrapnel or bullet.
  12. * Exclusion criteria for Gadolinium
  13. * Renal disease with estimated glomerular filtration rate \[eGFR\] \< 30 ml/min/1.73 m2 body surface area

Contacts and Locations

Study Contact

Laura Olivieri, MD
CONTACT
412-692-8664
olivierilj@upmc.edu
Joshua Kanter, MD
CONTACT
202-476-2020
jkanter@childrensnational.org

Principal Investigator

Laura Olivieri, MD
PRINCIPAL_INVESTIGATOR
Children's National

Study Locations (Sites)

Children's National Health System
Washington, District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Children's National Research Institute

  • Laura Olivieri, MD, PRINCIPAL_INVESTIGATOR, Children's National

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 Date2019-12-10
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2019-12-10
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Cardiomyopathy, cardiomegaly
  • cardiac transplant

Additional Relevant MeSH Terms

  • Heart Failure
  • Cardiac Imaging Techniques
  • Congenital Heart Defects