Contrast Enhanced Resonance Angiography (MRA) in the Diagnosis of Atherosclerotic Disease: A Pilot Technical Development Study
Data Collection
Arterial Occlusive Diseases+2
+ Cardiovascular Diseases
+ Vascular Diseases
Summary
Study start date: March 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Warren G. Magnuson Clinical Center (CC)
Bethesda, United StatesOpen Warren G. Magnuson Clinical Center (CC) in Google Maps