Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging in Normal Volunteers
NCT ID: NCT00720460
Last Updated: 2019-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
107 participants
OBSERVATIONAL
2008-07-18
2018-11-02
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Experimental
Healthy Volunteers
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
* 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.
18 Years
99 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Responsible Party
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Principal Investigators
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Robert J Lederman, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Locations
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Countries
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References
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Lederman RJ. Cardiovascular interventional magnetic resonance imaging. Circulation. 2005 Nov 8;112(19):3009-17. doi: 10.1161/CIRCULATIONAHA.104.531368. No abstract available.
Haustein J, Laniado M, Niendorf HP, Louton T, Beck W, Planitzer J, Schoffel M, Reiser M, Kaiser W, Schorner W, et al. Triple-dose versus standard-dose gadopentetate dimeglumine: a randomized study in 199 patients. Radiology. 1993 Mar;186(3):855-60. doi: 10.1148/radiology.186.3.8430199.
Niendorf HP, Haustein J, Cornelius I, Alhassan A, Clauss W. Safety of gadolinium-DTPA: extended clinical experience. Magn Reson Med. 1991 Dec;22(2):222-8; discussion 229-32. doi: 10.1002/mrm.1910220212.
Saybasili H, Kellman P, Griswold MA, Derbyshire JA, Guttman MA. HTGRAPPA: real-time B1-weighted image domain TGRAPPA reconstruction. Magn Reson Med. 2009 Jun;61(6):1425-33. doi: 10.1002/mrm.21922.
Other Identifiers
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08-H-0185
Identifier Type: -
Identifier Source: secondary_id
080185
Identifier Type: -
Identifier Source: org_study_id