CompletedNot Applicable

MRI to Predict Rejection and Failure in Transplant and Cardiomyopathy Patients

United States113 participantsStarted 2019-12-10

Plain-language 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.

Who can participate

Age range6 Months

SexALL

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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 rema…

What they're measuring

Correlate MRI imaging results to biopsy results Correlate MRI imaging with endomyocardial biopsy

Timeframe: At the end of each catheterization procedure through study completion,up to 5 years

Trial details

NCT IDNCT03822442

SponsorChildren's National Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-11-30