Using MRI to predict rejection and failure in heart transplant and cardiomyopathy patients
Cardiac MRI Increases Accuracy and Decreases Risk of Evaluation of Children with Cardiomyopathy and Cardiac Transplantation
This study is testing a new way to use MRI scans to help doctors better understand and predict heart problems in kids with cardiomyopathy and those who have had heart transplants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | Children's National Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Washington, District of Columbia) |
| Trial ID | NCT03822442 on ClinicalTrials.gov |
What this trial studies
This study aims to refine and validate noninvasive cardiac MRI imaging techniques to assess pediatric patients with cardiomyopathy and those who have undergone heart transplants. It involves correlating MRI findings with invasive hemodynamic and pathology results to improve diagnostic accuracy. The approach includes performing MRI-guided catheterization to obtain real-time imaging and hemodynamic data, ultimately aiming to create a comprehensive, radiation-free assessment regimen. The study leverages the institution's extensive experience in MR-guided cardiac procedures to enhance patient care.
Who should consider this trial
Good fit: Ideal candidates include children and adults with heart transplants or suspected/confirmed cardiomyopathy who require cardiovascular catheterization.
Not a fit: Patients with cardiovascular instability or certain medical devices that are not MRI safe may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved noninvasive assessment methods for heart transplant and cardiomyopathy patients, reducing the need for invasive procedures.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for cardiac assessment, but this specific approach is innovative and builds on existing methodologies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Washington, District of Columbia
- Children's National Health System — Washington, District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Laura Olivieri, MD — Children's National
- Study coordinator: Laura Olivieri, MD
- Email: olivierilj@upmc.edu
- Phone: 412-692-8664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.