NCT00001841

Brief Summary

Magnetic Resonance Angiography (MRA) is a method used to evaluate arteries and veins without the use of invasive catheters or x-rays (radiation). MRA technique has been continuously improving and has become more accurate at diagnosing problems of narrowing in blood vessels. However, MRA has a difficult time detecting narrowing in small blood vessels, limiting its use to large arteries. The purpose of this study is to recruit patients diagnosed with or suspected of having, atherosclerosis (hardening of the arteries) to participate in a series of new state-of-the-art diagnostic tests using MRA. This study is a combined effort between the National Institutes of Health (NIH), Uniformed Services University of the Health Sciences (USUHS), and General Electric Medical Services and is supported a Cooperative Research Agreement is to (CRADA). The goal of this study is to improve MRA to the point that it can reliably replace diagnostic x-ray catheter angiography in the evaluation of patients with atherosclerosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

December 1, 2004

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

ArteriosclerosisImagingMRANarrowing of VesselsHardening of Arteries

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must live in the Metropolitan Washington Area.
  • Patients must have suspected atherosclerotic disease based on clinical findings or documented by angiography or doppler ultrasound performed within 3 months of the MRA.
  • Patients must be willing to participate in the protocol.
  • Patients must be referred by a physician who is caring for the patient and to whom the results will be provided.
  • Patients must be clinically stable and be judged by their physician able to come to the Clinical Center to participate in the study.
  • Patients must have serum Creatinine value less than 3.0 mg/dl.

You may not qualify if:

  • Any contraindication for MRI including:
  • (a) pacemaker or other implanted electronic device; (b) cochlear implants; (c) metal in the eye; (d) embedded shrapnel fragments; (e) cerebral aneurysm clips; or (f) medical infusion pumps.
  • Allergy to Gadolinium based contrast media.
  • Unsatisfactory performance status as judged by the referring physician such that the patient could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include angina, dyspnea at rest, congestive heart failure, severe claudication (less than 1 flight of steps).
  • Intercurrent illness that requires treatment that would be jeopardized by the MRA scan.
  • Subjects requiring sedation for MRI studies.
  • Pregnant female.
  • Patients with severe back-pain who will be unable to tolerate supine positioning within the MRI scanner for the duration of the examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Warren G. Magnuson Clinical Center (CC)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Prince MR, Yucel EK, Kaufman JA, Harrison DC, Geller SC. Dynamic gadolinium-enhanced three-dimensional abdominal MR arteriography. J Magn Reson Imaging. 1993 Nov-Dec;3(6):877-81. doi: 10.1002/jmri.1880030614.

    PMID: 8280977BACKGROUND
  • Prince MR. Peripheral vascular MR angiography: the time has come. Radiology. 1998 Mar;206(3):592-3. doi: 10.1148/radiology.206.3.9494471. No abstract available.

    PMID: 9494471BACKGROUND
  • Prince MR. Contrast-enhanced MR angiography: theory and optimization. Magn Reson Imaging Clin N Am. 1998 May;6(2):257-67.

    PMID: 9560485BACKGROUND

MeSH Terms

Conditions

AtherosclerosisArteriosclerosis

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

March 1, 1999

Study Completion

December 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-12

Locations