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

This study has been completed.
Sponsor:
Collaborators:
Surgi-Vision Inc
Merck Sharp & Dohme Corp.
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00125060
First received: July 28, 2005
Last updated: August 9, 2005
Last verified: February 2004
  Purpose

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.


Condition Intervention
Heart Diseases
Drug: Simvastatin (20mg versus 80mg/day)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Transesophageal MRI in Conjunction With Lipid Lowering Measures

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • change in aortic atherosclerotic plaque area and volume on transesophageal and surface MRI

Secondary Outcome Measures:
  • serum levels of inflammatory markers like CRP, IL-6,TNF-α
  • cardiovascular events and stroke during follow-up

Estimated Enrollment: 72
Study Start Date: August 2000
Estimated Study Completion Date: April 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125060

Locations
United States, Maryland
Johns Hopkins - School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Surgi-Vision Inc
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Joao AC Lima, MD, MBA Johns Hopkins University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00125060     History of Changes
Other Study ID Numbers: 03-12-17-04, M681-217-84250
Study First Received: July 28, 2005
Last Updated: August 9, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Aorta
Atherosclerosis
MRI
statin
inflammatory markers

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014