Comparison of Magnetic Resonance Angiography and Standard Angiography in Diagnosing Atherosclerosis

March 3, 2008 updated by: National Institutes of Health Clinical Center (CC)

A Comparison of Contrast Enhanced Magnetic Resonance Angiography (MRA) and Conventional Angiography in the Diagnosis of Atherosclerotic Disease: A Pilot Study

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 patient's 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 patient's 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Warren G. Magnuson Clinical Center (CC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patient must be willing to participate in the study.

Patient must have documented atherosclerotic disease of an extracranial vessel by angiography performed within 72 hours of the MRA.

Patient must be referred by a physician who is caring for the patient and to whom the results will be provided.

Patient must be clinically stable and be judged by their physician able to tolerate lying in the MR gantry for up to 1.5 hours.

Patient must have serum Creatinine value less than 3.0mg/dl.

Must not have any contraindication for MRI including: pacemaker or other implanted electronic device; cochlear implants; metal in the eye; embedded shrapnel fragments; cerebral aneurysm clips; or medical Infusion pumps.

Must not have an allergy to Gadolinium based contrast media.

Must not have unsatisfactory performance status as judged by the referring physician such that the patient could not tolerate an MRI scan for 1.5 hours. Examples of medical conditions that would not be accepted would include unstable angina, dyspnea at rest, severe pain at rest, and severe back pain.

Must not have intercurrent illness that requires treatment that would be jeopardized by the MRA scan.

Subjects must not require sedation for MRI studies other than administered normally for a conventional angiogram.

Must not be pregnant.

Must not be nursing mothers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1999

Study Completion

September 1, 2002

Study Registration Dates

First Submitted

January 18, 2000

First Submitted That Met QC Criteria

January 18, 2000

First Posted (Estimate)

January 19, 2000

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

September 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000028
  • 00-CC-0028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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