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Technical Evaluation of Cardiovascular Magnetic Resonance Imaging and Spectroscopy

This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), September 2008

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001874
  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

MedlinePlus related topics:   MRI Scans   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Technical Evaluation of Cardiovascular Magnetic Resonance Imaging and Spectroscopy

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:   400
Study Start Date:   February 1999

Detailed Description:

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

Criteria
  • 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.

  1. Brain aneurysm clip
  2. Implanted neural stimulator
  3. Implanted cardiac pacemaker implanted defibrillator
  4. Cochlear implant
  5. Ocular foreign body (e.g. metal shavings)
  6. Insulin pump
  7. Pregnant women (when uncertain, subjects will undergo urine or blood testing).
  8. Kidney
  9. Paralyzed hemidiaphragm
  10. Morbid obesity
  11. Claustrophobia
  12. Any condition in the PI's judgement which present unncessary risk

EXCLUSION CRITERIA FOR GADOLINIUM ENHANCED STUDIES:

  1. Lactating women
  2. Subjects with hemoglobinopathies
  3. Asthma
  4. 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001874

Contacts
Contact: Patient Recruitment and Public Liaison Office     (800) 411-1222     prpl@mail.cc.nih.gov    
Contact: TTY     1-866-411-1010    

Locations
United States, Maryland
Suburban Hospital     Recruiting
      Bethesda, Maryland, United States, 20814

Sponsors and Collaborators
  More Information


NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   990048, 99-H-0048
First Received:   November 3, 1999
Last Updated:   October 21, 2008
ClinicalTrials.gov Identifier:   NCT00001874
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

Study placed in the following topic categories:
Healthy

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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