Technical Evaluation of Cardiovascular Magnetic Resonance Imaging and Spectroscopy
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Purpose
Magnetic resonance imaging (MRI) and spectroscopy are diagnostic tools that create high quality images of the human body without the use of X-ray (radiation). MRI uses different levels of magnetic fields to create images of the body and organs. Occasionally, researchers will give patients undergoing a MRI an injection of a contrast substance. The contrast substance works by brightening areas of the magnetic resonance image.
In this study researchers plan to use magnetic resonance imaging with contrast substances and exercise on normal volunteers in order to evaluate different aspects of its performance. Information gathered from this study may be used to develop more specific research studies involving MRI....
| Condition |
|---|
|
Cardiovascular Disease Healthy |
| Study Type: | Observational |
| Official Title: | Technical Evaluation of Cardiovascular Magnetic Resonance Imaging and Spectroscopy |
| Estimated Enrollment: | 400 |
| Study Start Date: | February 1999 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Technical evaluation of magnetic resonance imaging and spectroscopy will be performed on normal volunteers. These studies will be conducted in the NIH MRI systems located in Suburban Hospital in Bethesda, Maryland. These studies may involve the intravenous administration of commercially available MR contrast media and exercise. The results will be used to evaluate the performance of various pulse sequences, gradient coils, and RF coils on human subjects and will provide essential ground work for specific patient protocols.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
- INCLUSION CRITERIA:
Any normal volunteer above the age 18 who is capable of giving informed consent will be included.
EXCLUSION CRITERIA:
A subject will be excluded if he/she has a contradiction to MR scanning.
- Brain aneurysm clip
- Implanted neural stimulator
- Implanted cardiac pacemaker implanted defibrillator
- Cochlear implant
- Ocular foreign body (e.g. metal shavings)
- Insulin pump
- Pregnant women (when uncertain, subjects will undergo urine or blood testing).
- Kidney
- Paralyzed hemidiaphragm
- Morbid obesity
- Claustrophobia
- Any condition in the PI's judgement which present unncessary risk
EXCLUSION CRITERIA FOR GADOLINIUM ENHANCED STUDIES:
- Lactating women
- Subjects with hemoglobinopathies
- Asthma
- Renal or hepatic disease
Subjects will be excluded if it is deemed that they have a condition that would preclude their use for technical development (e.g. paralyzed hemidiaphragm, morbid obesity, claustrophobia etc.) or present unnecessary risk (e.g. pregnancy, surgery of uncertain type, etc.).
Lactating women and subjects with hemoglobinopathies, asthma, or renal or hepatic disease will be excluded from studies involving the adminstration of contrast agents.
Contacts and Locations More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00001874 History of Changes |
| Other Study ID Numbers: | 990048, 99-H-0048 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 15, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Imaging Spectroscopy MRI Cardiovascular Technical Development Safety |
Gadolinium Heart Toxicity Adverse Events Normal Volunteer |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013