Status:
COMPLETED
Cardiovascular Magnetic Resonance Imaging of Pediatric Normal Volunteers
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Healthy
Eligibility:
All Genders
8-21 years
Brief Summary
This study will examine ways to establish and standardize normal measurements for children, specific to gender, age, and body surface, when using magnetic resonance imaging (MRI). MRI, which was intro...
Detailed Description
A cardiac MRI (Magnetic Resonance Imaging) scan will be performed on normal children and young adult volunteers. These studies will be conducted in the MRI systems located in the NIH Clinical Center i...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Any normal volunteer between the ages of 8 and 21 years old, non-smoker who is capable of giving assent and has a legal guardian to give informed consent if under 18 years old.
- EXCLUSION CRITERIA:
- A subject will be excluded if he/she has a contraindication to MR scanning.
- Brain aneurysm clip
- Implanted neural stimulator
- Implanted cardiac pacemaker or defibrillator
- Cochlear implant
- Ocular foreign body (e.g. metal shavings)
- Insulin pump
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- To assess whether subjects are indeed normal, the legal guardian will be asked to fill out a questionnaire. Subjects also will be excluded for a paralyzed hemidiaphragm, morbid obesity (BMI greater than 30%), claustrophobia, smokers, significant asthma (greater than one asthma attack per month for the past three months), pregnancy, major medical illness requiring regular medications (such as steroids that may alter muscle mass, sickle cell disease, thalassemia), history of cardiac disease (requiring SBE prophylaxis when visiting the dentist), and/or history of significant previous surgery that may alter cardiac anatomy (such as diaphragmatic hernia, tracheoesophageal fistula).
- Females of menstruating age will receive a pregnancy test as part of the screening process to participate in this protocol. If they do not wish to be tested, they cannot participate in this voluntary protocol.
Exclusion
Key Trial Info
Start Date :
July 14 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 26 2017
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00353899
Start Date
July 14 2006
End Date
April 26 2017
Last Update
December 9 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892