- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001841
Magnetic Resonance Angiography (MRA) for the Diagnosis of Atherosclerosis
Contrast Enhanced Resonance Angiography (MRA) in the Diagnosis of Atherosclerotic Disease: A Pilot Technical Development Study
Magnetic Resonance Angiography (MRA) is a method used to evaluate arteries and veins without the use of invasive catheters or x-rays (radiation). MRA technique has been continuously improving and has become more accurate at diagnosing problems of narrowing in blood vessels. However, MRA has a difficult time detecting narrowing in small blood vessels, limiting its use to large arteries.
The purpose of this study is to recruit patients diagnosed with or suspected of having, atherosclerosis (hardening of the arteries) to participate in a series of new state-of-the-art diagnostic tests using MRA.
This study is a combined effort between the National Institutes of Health (NIH), Uniformed Services University of the Health Sciences (USUHS), and General Electric Medical Services and is supported a Cooperative Research Agreement is to (CRADA).
The goal of this study is to improve MRA to the point that it can reliably replace diagnostic x-ray catheter angiography in the evaluation of patients with atherosclerosis.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- Warren G. Magnuson Clinical Center (CC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
Patients must live in the Metropolitan Washington Area.
Patients must have suspected atherosclerotic disease based on clinical findings or documented by angiography or doppler ultrasound performed within 3 months of the MRA.
Patients must be willing to participate in the protocol.
Patients must be referred by a physician who is caring for the patient and to whom the results will be provided.
Patients must be clinically stable and be judged by their physician able to come to the Clinical Center to participate in the study.
Patients must have serum Creatinine value less than 3.0 mg/dl.
EXCLUSION CRITERIA:
Any contraindication for MRI including:
(a) pacemaker or other implanted electronic device; (b) cochlear implants; (c) metal in the eye; (d) embedded shrapnel fragments; (e) cerebral aneurysm clips; or (f) medical infusion pumps.
Allergy to Gadolinium based contrast media.
Unsatisfactory performance status as judged by the referring physician such that the patient could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include angina, dyspnea at rest, congestive heart failure, severe claudication (less than 1 flight of steps).
Intercurrent illness that requires treatment that would be jeopardized by the MRA scan.
Subjects requiring sedation for MRI studies.
Pregnant female.
Patients with severe back-pain who will be unable to tolerate supine positioning within the MRI scanner for the duration of the examination.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Prince MR, Yucel EK, Kaufman JA, Harrison DC, Geller SC. Dynamic gadolinium-enhanced three-dimensional abdominal MR arteriography. J Magn Reson Imaging. 1993 Nov-Dec;3(6):877-81. doi: 10.1002/jmri.1880030614.
- Prince MR. Peripheral vascular MR angiography: the time has come. Radiology. 1998 Mar;206(3):592-3. doi: 10.1148/radiology.206.3.9494471. No abstract available.
- Prince MR. Contrast-enhanced MR angiography: theory and optimization. Magn Reson Imaging Clin N Am. 1998 May;6(2):257-67.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 990061
- 99-CC-0061
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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