MRI to Predict Rejection and Failure in Transplant and Cardiomyopathy Patients

Launched by CHILDREN'S NATIONAL RESEARCH INSTITUTE · Jan 28, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how advanced imaging techniques, specifically cardiac magnetic resonance (CMR) imaging, can help doctors better understand and predict heart transplant rejection and heart problems in children and adults with cardiomyopathy (a disease of the heart muscle). The goal is to improve care by using non-invasive imaging methods, which means no surgery or radiation exposure, to assess heart conditions more effectively. The researchers will compare results from these imaging techniques with results from standard heart tissue biopsies to see how well they work together in diagnosing issues.

To be eligible for this trial, participants must be children or adults who have had a heart transplant or have been diagnosed with cardiomyopathy and are scheduled for a necessary heart procedure. However, individuals who are pregnant, nursing, or have certain medical devices, like a non-MR safe pacemaker or defibrillator, cannot participate. Those involved in the trial can expect a thorough assessment using cutting-edge imaging technology and will contribute to important research that could lead to better treatment options for heart conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children and adults of any age with heart transplant, suspected or confirmed cardiomyopathy
• • Undergoing clinically-indicated ("medically necessary") cardiovascular catheterization
• Exclusion Criteria:
• • Cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support.
• • Women who are pregnant
• • Women who are nursing and who do not plan to discard breast milk for 24 hours
• • Exclusion criteria for MRI
• • Central nervous system aneurysm clips
• • Implanted neural stimulator
• • Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
• • Cochlear implant
• • Ocular foreign body (e.g. metal shavings)
• • Implanted Insulin pump
• • Metal shrapnel or bullet.
• • Exclusion criteria for Gadolinium
• • Renal disease with estimated glomerular filtration rate \[eGFR\] \< 30 ml/min/1.73 m2 body surface area
• • The eGFR will be used to estimate renal function if reported by the laboratory.
• The Schwartz equation 33 for estimation of GFR in children as recommended by the NKDEP is as follows:
• • GFR (mL/min/1.73 m2) = (k × height) / serum creatinine concentration
• • where k = constant defined as follows: k = 0.33 in premature infants k = 0.45 in term infants to 1 year of age k = 0.55 in children to 13 years of age k = 0.70 in adolescent males (not females because of the presumed increase in male muscle mass, the constant remains 0.55 for females) Height in cm Serum creatinine in mg/dL