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



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:8/25/2017
Start Date:August 2000
End Date:April 2004

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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.

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.
We found this trial at
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Baltimore, Maryland 21287
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