Cardiovascular Disease, Congenital Heart Disease
Conditions
Brief summary
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.
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.
Interventions
None listed
Sponsors
Children's National Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | through study completion, an average of 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Natural history of congenital heart disease | through study completion, an average of 1 year | 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. |
Countries
United States
Outcome results
None listed