MRI Detection of Vascular Inflammation in Patients Undergoing Peripheral Angioplasty
Magnetic resonance imaging
Arterial Occlusive Diseases+7
+ Arteriosclerosis
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: January 1, 2000
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, United StatesOpen National Heart, Lung and Blood Institute (NHLBI) in Google Maps