Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353899
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2006-07-18
Brief Title:
Cardiovascular Magnetic Resonance Imaging of Pediatric Normal Volunteers
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cardiovascular Magnetic Resonance Imaging of Pediatric Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2017-04-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 introduced in the 1980s is being used more frequently for children In this study researchers seek to understand how a childs 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
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
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-H-0208 | None | None | None |