Magnetic Resonance Imaging to Detect Blood Vessel Inflammation in Patients Undergoing Peripheral Balloon Angioplasty

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00004549
First received: February 3, 2000
Last updated: March 3, 2008
Last verified: January 2002
  Purpose

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 Intervention Phase
Atherosclerosis
Peripheral Vascular Disease
Procedure: Magnetic resonance imaging
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: MRI Detection of Vascular Inflammation in Patients Undergoing Peripheral Angioplasty

Resource links provided by NLM:


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

Estimated Enrollment: 20
Study Start Date: January 2000
Estimated Study Completion Date: January 2002
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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004549

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

Publications:
ClinicalTrials.gov Identifier: NCT00004549     History of Changes
Other Study ID Numbers: 000065, 00-H-0065
Study First Received: February 3, 2000
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Atherosclerosis
Endothelium
Peripheral Vascular Disease
Markers of Inflammation
Claudication

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Inflammation
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014