Magnetic Resonance Imaging to Detect Blood Vessel Inflammation in Patients Undergoing Peripheral Balloon Angioplasty
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ClinicalTrials.gov Identifier: NCT00004549 |
Recruitment Status
:
Completed
First Posted
: February 4, 2000
Last Update Posted
: March 4, 2008
|
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This study will examine the use of magnetic resonance imaging (MRI) in detecting blood vessel inflammation. The results of this study may later be applied to diagnosing inflammation of arteries in patients with atherosclerosis, predicting disease progression in these patients, and guiding therapy.
Patients with peripheral artery disease (for example, blockage of a leg artery) undergoing balloon angioplasty at Suburban Hospital in Bethesda, Maryland, may be eligible to participate in this study. Because this procedure, which opens blocked arteries, can cause inflammation in the vessel wall, it affords an opportunity for studying MRI detection of such inflammation.
Study candidates will be screened with a medical history and physical examination. Participants will have a MRI scan and blood drawn at Suburban Hospital before the angioplasty and again either 1 to 3 days or 2 weeks after the procedure. Before the MRI scan is begun, a catheter (a thin plastic tube) is inserted in an arm vein and 90 milliliters (about 3 ounces) of blood is drawn. The patient then lies on a table that slides into the MRI scanner-a large donut-shaped machine with a magnetic field. A flexible, padded sensor called an MRI coil is placed over the area to be imaged; this device is used to improve the quality of the pictures. During the scan a contrast material called gadolinium is injected through the catheter. Gadolinium brightens the image of the blood vessels. The procedure lasts up to 2 hours.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atherosclerosis Peripheral Vascular Disease | Procedure: Magnetic resonance imaging | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 20 participants |
Primary Purpose: | Treatment |
Official Title: | MRI Detection of Vascular Inflammation in Patients Undergoing Peripheral Angioplasty |
Study Start Date : | January 2000 |
Study Completion Date : | January 2002 |

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Must have clinically significant peripheral arterial disease and be referred from their physician for peripheral vascular angioplasty in the Suburban Hospital Radiology department.
Must be capable of giving informed consent.
Must be at least 18 years of age.
Must not have a history of severe claustrophobia.
Must not have a history of involuntary motion disorder.
Must not have a serum creatinine level greater than 2.0 mg/dL.
Must not have cardiac pacemaker or implantable defibrillator, aneurysm clip, neural stimulator (e.g. TENS-Unit), any type of ear implant, or metal in the eye (e.g. from machining).
Must not have systemic inflammatory disorder (e.g. systemic lupus erythematosus, rheumatoid arthritis, polyarteritis nodosa, Reiter's Syndrome).
Must not have the placement of a metal stent in the region to be imaged at the time of angioplasty.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004549
United States, Maryland | |
National Heart, Lung and Blood Institute (NHLBI) | |
Bethesda, Maryland, United States, 20892 |
Publications:
ClinicalTrials.gov Identifier: | NCT00004549 History of Changes |
Other Study ID Numbers: |
000065 00-H-0065 |
First Posted: | February 4, 2000 Key Record Dates |
Last Update Posted: | March 4, 2008 |
Last Verified: | January 2002 |
Keywords provided by National Institutes of Health Clinical Center (CC):
Atherosclerosis Endothelium Peripheral Vascular Disease Markers of Inflammation Claudication |
Additional relevant MeSH terms:
Inflammation Atherosclerosis Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease |
Pathologic Processes Arteriosclerosis Arterial Occlusive Diseases Cardiovascular Diseases |