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View Clinical Trial (Medical Research Study)
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Cardiovascular Magnetic Resonance Imaging of Pediatric Normal Volunteers - NCT00353899-20892 (Clinical Trial 146774)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy146774.aspx
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| City: |
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Bethesda |
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State:
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MD |
| Zip Code: |
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20892 |
| Conditions: |
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Healthy |
| Purpose: |
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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 introduced in the 1980s, is being used more frequently for children. In this
study, researchers seek to understand how a child's heart is different from that of an
adult, when an MRI is used for tests. More children with congenital heart disease are living
longer. Researchers are looking for a better way to assess their cardiac anatomy and
function, and to compare findings with normal function.
Patients ages 8 to 21 in good health and who do not smoke may be eligible for this study.
There will be a blood or urine test to check for pregnancy in female volunteers who have
begun menstruating or who are over age 12. Pregnancy test results must be negative for those
patients to stay in the study. The MRI technique uses a strong magnetic field and radio
waves to obtain images of body organs and tissues. For that procedure, patients will lie
still on a table that slides into the enclosed tunnel of the scanner. They will be in the
scanner from 20 to 60 minutes. As the scanner takes pictures, patients will hear knocking or
beeping sounds, and they will wear earplugs to reduce the noise. Patients will be able to
communicate with the MRI staff at all times during the scan. At any time, patients or their
parents may ask that the patients be moved out of the machine. If they would like, patients
can bring a music CD or listen to a radio station through headphones. Some MRI techniques
require monitoring while the patient is undergoing the scan. For monitoring of the heart, an
electrocardiogram (EKG) will be performed to make sure that the heart rhythm is normal and
that heart disease is not present. Patients may be asked to wear adhesive patches that are
attached to wires of the EKG machine on their chests. To monitor breathing, patients may be
asked to wear a rubber belt that stretches as they take a breath. So that the best quality
images are produced, patients may be asked to hold their breath for about 15 seconds.
During the MRI scan, patients may experience peripheral nerve stimulation, usually
experienced as a muscle twitch. It is caused by rapid switching of magnetic fields and is
not serious. Patients who feel a muscle twitch should report that sensation to the person
performing the scan. It is possible, though unlikely, for a painful sensation to result from
nerve stimulation. Patients should immediately report if they have pain so that the scan can
be stopped.
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| Study summary: |
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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 in Bethesda, Maryland. The results will be used to establish the normal
standard MRI measurements for the pediatric population; including left ventricular mass,
ejection fractions and other standard cardiac measurements. |
| Criteria: |
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- 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.
1. Brain aneurysm clip
2. Implanted neural stimulator
3. Implanted cardiac pacemaker or defibrillator
4. Cochlear implant
5. Ocular foreign body (e.g. metal shavings)
6. Insulin pump
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. |
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| Study is available at: |
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD 20892
United States
Primary Contact:
Patient Recruitment and Public Liaison Office
Email: prpl@mail.cc.nih.gov
Phone: (800) 411-1222 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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