Technical Development for Pediatric Cardiovascular MRI

N/AActive Not RecruitingNCT02892136

Children's National Research Institute5,000 enrolled

Overview

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.

The purpose of this protocol is to allow development and testing of new MRI techniques suitable for evaluating patients with cardiovascular disease, congenital heart disease, fetal cardiac structure, function, and physiology, and other fetal organ analysis. Individuals referred to Children's National Medical Center for a clinically indicated cardiac MRI or cardiac catheterization by their primary referring cardiologist or obstetrician, and who are enrolled in this study may also undergo additional research imaging. Since such technical development work often depends on preliminary studies in healthy volunteers, the protocol also recruits healthy subjects.

Study Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Congenital Heart Disease Cardiovascular Disease

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Clinically indicated exams 1. Patients who are undergoing a medically indicated MRI scan or cardiac catheterization procedure 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 Volunteers 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 Fetal exams 1. Age inclusion:18 years and older 2. Second or third trimester (greater than 13 weeks) Exclusion Criteria: 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 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 4. Exclusion criteria for volunteers undergoing both contrast and non-contrast MRI scans: * Pregnant women: 1. Women of childbearing potential will be required to have a screening urine pregnancy test 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

Locations (1)

Children's National Health System

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

Outcomes

Primary Outcomes

To evaluate innovative noninvasive MRI techniques suitable for evaluating pediatric patients with cardiovascular disease, congenital cardiac disease, and fetal organ analysis including cardiac structure, function, and physiology.

Time frame: through study completion, an average of 1 year

Secondary Outcomes

Natural history of congenital heart disease

A secondary objective of this protocol is to catalog results from MR imaging studies that can be used to describe the natural history of congenital heart disease and other cardiovascular diseases acquired in the young.

Time frame: through study completion, an average of 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.