Heart Diseases Clinical Trial
Official title:
Transesophageal MRI in Conjunction With Lipid Lowering Measures
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.
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.
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