Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004549
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-02-03
Brief Title:
Magnetic Resonance Imaging to Detect Blood Vessel Inflammation in Patients Undergoing Peripheral Balloon Angioplasty
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
MRI Detection of Vascular Inflammation in Patients Undergoing Peripheral Angioplasty
Status:
COMPLETED
Status Verified Date:
2002-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-H-0065 | None | None | None |