Transesophageal Magnetic Resonance Imaging (MRI) in Conjunction With Lipid Lowering Measures
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Interventional

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.
    

Detailed description: 
      Using a new MRI coil developed by Hopkins researchers, the investigators are now able to
      image aortic atherosclerotic plaques in exquisite detail. This coil is placed into the
      esophagus via a small nasogastric tube and positioned next to the descending thoracic aorta.
      Using this method of transesophageal MRI (TEMRI), the investigators are able not only to
      measure the extent of aortic atherosclerosis and the size of individual plaques, but they can
      now image in such detail as to obtain information about plaque composition. The extent of
      aortic atherosclerosis has been correlated with cardiovascular events including heart attack
      and stroke. The investigators now propose to use this new imaging technique to study the
      effect of aggressive lipid lowering measures on patients with aortic atherosclerosis.

      They plan to randomize patients with documented vascular disease to high dose (simvastatin
      80mg) versus low dose (simvastatin 20mg) cholesterol lowering medications. The investigators
      expect to show a decrease in the extent of atherosclerosis, a change in plaque morphology and
      composition, and perhaps a decrease in cardiovascular events in the aggressive care group of
      patients.

      They also plan to measure serum markers of inflammation in these patients at baseline and
      after therapy. C-reactive protein is the most studied of the markers that are independently
      correlated with cardiovascular events. The investigators hope to show that TEMRI correlates
      higher levels of C-reactive protein with more baseline atherosclerosis, and that treatment
      with high dose statin therapy reduces levels of inflammatory markers.

      Finally they plan to store plasma collected on these patients to save for future studies of
      cardiac markers, which could then be correlated with the effect of statin therapy and the
      reduction in aortic atherosclerosis as documented by TEMRI.
    

Intervention name(s): Simvastatin (20mg versus 80mg/day)
Intervention type(s): Drug
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Aorta; Atherosclerosis; MRI; statin; inflammatory markers