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

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

Plain Language Summary

Simplified for easier understanding

This study is investigating whether MRI scans (detailed body imaging that does not use radiation) can detect early signs of heart transplant rejection or heart muscle disease (cardiomyopathy) before patients get very sick, potentially replacing or reducing the need for invasive procedures like heart biopsies. **You may be eligible if...** - You are a child or adult of any age who has had a heart transplant, or who has been diagnosed with or is suspected of having cardiomyopathy (a disease of the heart muscle) - You are already scheduled for a medically necessary heart catheterization procedure **You may NOT be eligible if...** - Your heart condition is unstable (for example, you need medications to maintain blood pressure or mechanical heart support) - You are pregnant or nursing and not willing to discard breast milk for 24 hours after the scan - You have metal implants, a pacemaker, cochlear implant, or other MRI-incompatible devices in your body - You have an ocular (eye) metal foreign body Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Children's National Health System

Washington D.C., District of Columbia, United States

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NCT03822442


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