Transesophageal Magnetic Resonance Imaging (MRI) in Conjunction With Lipid Lowering Measures
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|ClinicalTrials.gov Identifier: NCT00125060|
Recruitment Status : Completed
First Posted : July 29, 2005
Last Update Posted : August 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Diseases||Drug: Simvastatin (20mg versus 80mg/day)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Transesophageal MRI in Conjunction With Lipid Lowering Measures|
|Study Start Date :||August 2000|
|Study Completion Date :||April 2004|
- change in aortic atherosclerotic plaque area and volume on transesophageal and surface MRI
- serum levels of inflammatory markers like C-reactive Protein (CRP), Interleukin (IL-6), Tumor Necrosis Factor alpha(TNF-α)
- cardiovascular events and stroke during follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125060
|United States, Maryland|
|Johns Hopkins - School of Medicine|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Joao AC Lima, MD, MBA||Johns Hopkins University|