View Clinical Trial (Medical Research Study)
Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging in Normal Volunteers
| City: |
|
Bethesda |
| State: |
|
Maryland |
| Zip Code: |
|
20892 |
| Conditions: |
|
Healthy |
| Purpose: |
|
This study will test new techniques to image the heart, blood vessels, and legs using
magnetic resonance imaging (MRI). The techniques will be used to plan and guide treatments
using minimally invasive methods.
Healthy normal volunteers 18 years of age and older may be eligible for this study.
For MRI, the subject lies flat on a table that can slide in and out of the scanner, a metal
cyclinder. Special antennas, covered in pads, are placed against the subject's body. The
scan time can vary from 20 minutes to 2 hours, with most scans lasting between 45 and 90
minutes. The subject may be asked to wear adhesive patches on the chest for monitoring the
heart and a belt or finger pad for monitoring breathing. During the test, a contrast agent
called gadolinium may be injected. This substance brightens the heart and arteries during
the scan, providing a better picture of blood flow.
During the procedure, subjects may be asked to exercise their legs on a machine to evaluate
the effects of motion and exercise on the MRI exam.
Large blood pressures cuffs may be placed on either or both thighs or calves to try to
measure arterial flow to the legs. The cuffs are inflated to a pressure as high as at least
50 mmHg higher than thesubject's systolic blood pressure (up to 250 mmHg) for up to 10
minutes.
Subjects may be asked to return for repeated scans.
|
| Study Summary: |
|
We will evaluate new developments in fast magnetic resonance imaging (MRI) of the heart and
blood vessels on normal volunteers. These studies will be conducted in the NIH MRI systems
located at the NIH Clinical Center in Bethesda, Maryland. These procedures may involve the
intravenous administration of commercially available MR contrast media, supine exercise or
the inflation of blood pressure cuffs on the lower extremities during the MRI imaging. The
results will be used to evaluate the performance of various research pulse sequences,
gradient coils, and radiofrequency receiver coils on human subjects and will provide
essential ground work for specific patient protocols, both diagnostic and therapeutic.
|
| Criteria: |
|
- 1. GENERAL INCLUSION CRITERIA:
- Normal adult volunteers, age is greater than 18 years of age, who consent to
participate in writing
2. EXCLUSION CRITERIA: MRI risk
- Cardiac pacemaker or implantable defibrillator
- Cerebral aneurysm clip
- Implanted neural stimulator (e.g. TENS-Unit)
- Any type of ear or cochlear implant
- Intra-ocular foreign body (e.g. metal shavings)
- Any implanted device (e.g. insulin pump, drug infusion device)
- Metal shrapnel or bullet
- Morbid obesity
- Claustrophobia
3. EXCLUSION CRITERIA: Contrast media risk:
- Pregnant women (when uncertain, subjects will undergo urine or blood testing) or
lactating women
- Known hemoglobinopathy
- Known kidney disease
- Exposure to gadolinium MRI contrast agents in the past 18 hours, if the study
requires gadolinium MRI contrast agent.
- Diabetes
- Children are not included.
|
| NCT ID: |
|
NCT00720460 |
| Primary Contact: |
|
Principal Investigator
Robert J Lederman, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Annette Stine, R.N.
Phone: (301) 402-5558
Email: stinea@nhlbi.nih.gov
|
| Backup Contact: |
|
Email: lederman@nih.gov
Robert J Lederman, M.D.
Phone: (301) 402-6769
|
| Location Contact: |
|
Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
June 19, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|