RecruitingNCT03822442

MRI to Predict Rejection and Failure in Transplant and Cardiomyopathy Patients

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

Sponsor

Children's National Research Institute

Enrollment

200 participants

Start Date

Dec 10, 2019

Study Type

OBSERVATIONAL

Conditions

Heart Failure Cardiac Imaging Techniques Congenital Heart Defects

Summary

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.

Eligibility

Min Age: 6 Months

Inclusion Criteria2

Children and adults of any age with heart transplant, suspected or confirmed cardiomyopathy
Undergoing clinically-indicated ("medically necessary") cardiovascular catheterization

Exclusion Criteria15

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
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.
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