Purpose

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.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

More Details

NCT ID
NCT02892136
Status
Active, not recruiting
Sponsor
Children's National Research Institute

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.