Transesophageal Magnetic Resonance Imaging (MRI) in Conjunction With Lipid Lowering Measures

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This research is being done to investigate the ability of an experimental imaging method - transesophageal magnetic resonance imaging (TEMRI), to detect the change in aortic atherosclerotic plaque burden and morphology between patients on high dose cholesterol lowering medications and patients on standard dose cholesterol lowering medications. This study will use TEMRI to see how atherosclerosis (cholesterol build up) changes with cholesterol lowering medications. This study will also investigate whether these cholesterol-lowering medications will change levels of blood tests, called inflammatory markers, in patients' blood. People with atherosclerosis may join this study. This study will also store blood samples for future studies of cardiac diseases; no gene testing will be done.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: Merck Sharp & Dohme Corp.; Surgi-Vision Inc
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• Age greater than 18 years

• Required to have documented atherosclerosis in at least 1 vascular territory defined as: at least moderate (>3.9mm) aortic atherosclerosis seen on transesophageal echocardiography; or moderate coronary artery disease (>50% lesion) in at least 1 coronary artery seen at cardiac catheterization; or >50% carotid lesion seen on ultrasound; or clinically documented peripheral vascular disease.

Exclusion Criteria:

• Patients could be on any statin therapy at entry, but not on a dose equivalent to or greater than 80mg of simvastatin.

• Patients with pacemakers, automated implanted cardioverter defibrillators (AICD), aneurysm clips, abnormal nasopharyngeal anatomy, active peptic ulcer disease, severe dysphagia, elevated baseline liver transaminases and serum creatinine (greater than 2 times the normal), decompensated congestive heart failure or inability to give informed consent.