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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
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Description
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Brief Summary:

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

Detailed Description:
In this pilot study high resolution Magnetic Resonance Imaging (MRI) will be used to study 20 patients scheduled to undergo peripheral angioplasty in order to determine the MRI characteristics of acute and chronic vascular inflammation. The vascular territories to be angioplastied will be imaged in 20 patients with peripheral vascular disease prior to angioplasty. Patients will then be randomly assigned for imaging at 24-72 hours (10 patients) or imaging at 2-4 weeks (10 patients) post-angioplasty. Analysis will focus on paired comparisons between pre- and post-angioplasty data within each group. This study should provide data that can be applied to other research protocols designed to image inflammation associated with vascular injury and atherosclerosis.

Study Design
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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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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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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


Locations
United States, Maryland
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
More Information
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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