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

NCT00004549 | Completed Phase 1

• 2 other identifiers: 00006500-H-0065
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis; Peripheral Vascular Disease

Keywords

Atherosclerosis; Endothelium; Peripheral Vascular Disease; Markers of Inflammation; Claudication

Interventions

Magnetic resonance imaging PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Libby P. Molecular bases of the acute coronary syndromes. Circulation. 1995 Jun 1;91(11):2844-50. doi: 10.1161/01.cir.91.11.2844. No abstract available.

  PMID: 7758192 BACKGROUND

• Munro JM, Cotran RS. The pathogenesis of atherosclerosis: atherogenesis and inflammation. Lab Invest. 1988 Mar;58(3):249-61.

  PMID: 3279259 BACKGROUND

• Navab M, Fogelman AM, Berliner JA, Territo MC, Demer LL, Frank JS, Watson AD, Edwards PA, Lusis AJ. Pathogenesis of atherosclerosis. Am J Cardiol. 1995 Sep 28;76(9):18C-23C. doi: 10.1016/s0002-9149(99)80466-4.

  PMID: 7572682 BACKGROUND

MeSH Terms

Conditions

Atherosclerosis; Peripheral Vascular Diseases; Intermittent Claudication

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 3, 2000
• First Posted: February 4, 2000
• Study Start: January 1, 2000
• Study Completion: January 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-01

Locations

US (1)