Viewing Study NCT00001946



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001946
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 2000-01-18

Brief Title: Comparison of Magnetic Resonance Angiography and Standard Angiography in Diagnosing Atherosclerosis
Sponsor: National Institutes of Health Clinical Center CC
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: A Comparison of Contrast Enhanced Magnetic Resonance Angiography MRA and Conventional Angiography in the Diagnosis of Atherosclerotic Disease A Pilot Study
Status: COMPLETED
Status Verified Date: 2002-09
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 evaluate ways to improve magnetic resonance angiography MRA for diagnosing atherosclerosis hardening and narrowing of the arteries

MRA is a new method for looking at arteries and veins without standard angiography which requires inserting a catheter into a blood vessel injecting a contrast material and obtaining X-ray images Current MRA techniques however do not depict the lumen cavity of small vessels well enough to accurately determine the extent of their narrowing This study will test image processing methods with the eventual goal of improving MRA accuracy to the point that it can replace X-ray catheter angiography for diagnosing atherosclerotic disease

Patients with atherosclerosis who have had conventional angiography at Suburban Hospital in Bethesda MD may be considered for this study They will be screened with a brief history and physical examination and those enrolled will have a MRA scan within 72 hours of their conventional angiogram For this procedure a catheter is placed in a vein in the patients arm and the patient lies on a table that slides into a magnetic resonance imaging MRI scanner-a large donut-shaped machine with a magnetic field Surface coils-flexible padded antennae used to improve the quality of the pictures-are wrapped around the patients legs At times during the scan the patient is asked to hold his or her breath for several seconds and a contrast material called gadolinium is injected through the catheter in the vein This substance enhances the images of blood flow in the vessels The procedure generally takes about an hour and a half although the actual imaging takes only a small part of that time
Detailed Description: Contrast Enhanced Magnetic Resonance Angiography MRA is a developing technology for the non-invasive evaluation of arterial and venous structures which does not require x-ray based catheter angiography While dramatic progress in MRA has recently been made there are still substantial limitations in the accuracy of MRA in grading stenoses and detecting small accessory vessels The purpose of this study is to recruit patients with documented atherosclerotic disease as confirmed on catheter angiography performed at Suburban Hospital for evaluation with state-of-the-art MRA on MRI units also at Suburban Hospital We intend to test new surface coils new pulse sequence designs and advanced image processing algorithms in order to improve MRA accuracy to the point that a large-scale study of MRA vs conventional angiography is possible The goal of this pilot study is to improve MRA to the point that it can reliably replace diagnostic x-ray catheter angiography in the evaluation of patients with atherosclerotic disease

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-CC-0028 None None None