A Comparison of Contrast Enhanced Magnetic Resonance Angiography (MRA) and Conventional Angiography in the Diagnosis of Atherosclerotic Disease: A Pilot Study
Magnetic resonance angiography
Arterial Occlusive Diseases+2
+ Arteriosclerosis
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: December 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
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
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 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