Status:
RECRUITING
MRI to Predict Rejection and Failure in Transplant and Cardiomyopathy Patients
Lead Sponsor:
Children's National Research Institute
Conditions:
Heart Failure
Cardiac Imaging Techniques
Eligibility:
All Genders
6+ years
Brief 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...
Detailed Description
Anesthesia and Vascular Access After final review of protocol eligibility and of MRI safety, vascular access is obtained and sheaths are secured and covered with a sterile drape for transfer to the MR...
Eligibility Criteria
Inclusion
- Children and adults of any age with heart transplant, suspected or confirmed cardiomyopathy
- Undergoing clinically-indicated ("medically necessary") cardiovascular catheterization
Exclusion
- 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
Key Trial Info
Start Date :
December 10 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03822442
Start Date
December 10 2019
End Date
December 31 2026
Last Update
November 1 2024
Active Locations (1)
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1
Children's National Health System
Washington D.C., District of Columbia, United States, 20010