Protocol Number: 99-CC-0061

Title:

Contrast Enhanced Resonance Angiography (MRA) in the Diagnosis of Atherosclerotic Disease: A Pilot Technical Development Study

Number:

99-CC-0061

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.

Sponsoring Institute:

Warren G. Magnuson Clinical Center (CC)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

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.

Special Instructions: Currently Not Provided

Keywords:

Arteriosclerosis

Imaging

MRA

Narrowing of Vessels

Hardening of Arteries

Recruitment Keywords:

None

Conditions:

Atherosclerosis

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Dynamic gadolinium-enhanced three-dimensional abdominal MR arteriography

Peripheral vascular MR angiography: the time has come

MR contrast-enhanced MR angiography: theory and optimization

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Bethesda, Maryland 20892. Last update: 10/16/2004