This study will explore new ways of using magnetic resonance imaging (MRI) to evaluate
pediatric patients with cardiovascular disease,congenital heart disease in patients of all
ages, fetuses undergoing clinically indicated MR imaging.
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Locations near you
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Full eligibility criteria for NCT02892136
Ages eligible for Study
Genders eligible for Study
Accepts Healthy Volunteers
Clinically indicated exams
Patients who are undergoing a medically indicated MRI scan or cardiac catheterization procedure
Patients who are medically judged to have no contraindications to MRI scan
Age inclusion: infant to adult
Written informed consent and assent, when applicable Volunteers
Written informed consent from any normal volunteer 8 years of age or older for a noncontrast, nonsedated cardiac MRI
Normal adult volunteer to undergo cardiac MRI with contrast agent Fetal exams
Age inclusion:18 years and older
Second or third trimester (greater than 13 weeks)
All patients who are medically judged to have contraindication(s) to MRI scanning will be excluded. Contraindications include implanted metal devices which are contraindicated for MRI scanning:
Central nervous system aneurysm clips;
Implanted neural stimulator;
Implanted cardiac pacemaker or defibrillator;
Ocular foreign body (e.g. metal shavings);
Implanted Insulin pump;
Metal shrapnel or bullet.
Exclusion criteria for Bicycle Stress MRI
Myocardial infarction within 24 hours
Uncontrolled heart failure
Severe left ventricular outflow tract obstruction
Exclusion Criteria for adult volunteers undergoing MRI with administration of contrast agent:
60 years of age or older
Renal Disease; Glomerular Filtration rate (eGFR < 30 ml/min/1.73 m2) will be determined by a simple blood test done at the bedside
Use of diuretics
Diagnosis of hypertension and diabetes
Exclusion criteria for volunteers undergoing both contrast and non-contrast MRI scans:
Women of childbearing potential will be required to have a screening urine pregnancy test
Exclusion criteria for
Pregnant woman for whom 15 additional minutes lying flat in the MR scanner would represent a risk (i.e. severe claustrophobia, congestive heart failure)
Pregnant minor under the age of 18
Less than 13 weeks gestation
All locations for NCT02892136
United States (1)
Children's National Health System
Washington, District of Columbia, United States, 20010
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Tris trial is registered with FDA with number: NCT02892136. The sponsor of the trial is Children's National Research Institute and it is looking for 5000 volunteers for the current phase.
Official trial title: Technical Development for Pediatric Cardiovascular MRI
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