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Magnetic Resonance Angiography (MRA) for the Diagnosis of Atherosclerosis

Primary Purpose

Atherosclerosis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Atherosclerosis focused on measuring Arteriosclerosis, Imaging, MRA, Narrowing of Vessels, Hardening of Arteries

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.

Sites / Locations

  • Warren G. Magnuson Clinical Center (CC)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT00001841
Brief Title
Magnetic Resonance Angiography (MRA) for the Diagnosis of Atherosclerosis
Official Title
Contrast Enhanced Resonance Angiography (MRA) in the Diagnosis of Atherosclerotic Disease: A Pilot Technical Development Study
Study Type
Observational

2. Study Status

Record Verification Date
December 2004
Overall Recruitment Status
Completed
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

5. Study Description

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.
Detailed Description
Contrast Enhanced Magnetic Resonance Angiography (MRA) is a developing technology that permits the non-invasive evaluation of arterial and venous structures without the need for x-ray based catheter angiography. While dramatic progress has been made in the last few years, there are still substantial limitations in the accuracy of MRA in judging stenoses and detecting small accessory vessels. The purpose of this study is to recruit patients with suspected or documented atherosclerotic disease for evaluation with state-of-the-art MRA using new surface coils, new pulse sequence designs, novel contrast administration strategies, and advanced image processing algorithms. This work represents a collaboration between NIH, USUHS and General Electric Medical Systems and is supported by a Cooperative Research Agreement (CRADA). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
Arteriosclerosis, Imaging, MRA, Narrowing of Vessels, Hardening of Arteries

7. Study Design

Enrollment
100 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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.
Facility Information:
Facility Name
Warren G. Magnuson Clinical Center (CC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8280977
Citation
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.
Results Reference
background
PubMed Identifier
9494471
Citation
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.
Results Reference
background
PubMed Identifier
9560485
Citation
Prince MR. Contrast-enhanced MR angiography: theory and optimization. Magn Reson Imaging Clin N Am. 1998 May;6(2):257-67.
Results Reference
background

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Magnetic Resonance Angiography (MRA) for the Diagnosis of Atherosclerosis

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