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
1. Patients who are undergoing a medically indicated MRI scan or cardiac catheterization
2. Patients who are medically judged to have no contraindications to MRI scan
3. Age inclusion: infant to adult
4. Written informed consent and assent, when applicable
1. Written informed consent from any normal volunteer 8 years of age or older for a
noncontrast, nonsedated cardiac MRI
2. Normal adult volunteer to undergo cardiac MRI with contrast agent
1. Age inclusion:18 years and older
2. Second or third trimester (greater than 13 weeks)
1. 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;
- Cochlear implant;
- Ocular foreign body (e.g. metal shavings);
- Implanted Insulin pump;
- Metal shrapnel or bullet.
2. Exclusion criteria for Bicycle Stress MRI
- Myocardial infarction within 24 hours
- Active myocarditis
- Uncontrolled heart failure
- Severe left ventricular outflow tract obstruction
3. Exclusion Criteria for adult volunteers undergoing MRI with administration of contrast
- 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
4. Exclusion criteria for volunteers undergoing both contrast and non-contrast
- Pregnant women:
1. Women of childbearing potential will be required to have a screening urine
5. 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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