search
Back to results

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

Primary Purpose

Heart Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simvastatin (20mg versus 80mg/day)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Diseases focused on measuring Aorta, Atherosclerosis, MRI, statin, inflammatory markers

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Johns Hopkins - School of Medicine

Outcomes

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 C-reactive Protein (CRP), Interleukin (IL-6), Tumor Necrosis Factor alpha(TNF-α)
cardiovascular events and stroke during follow-up

Full Information

First Posted
July 28, 2005
Last Updated
August 23, 2017
Sponsor
Johns Hopkins University
Collaborators
Surgi-Vision Inc, Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT00125060
Brief Title
Transesophageal Magnetic Resonance Imaging (MRI) in Conjunction With Lipid Lowering Measures
Official Title
Transesophageal MRI in Conjunction With Lipid Lowering Measures
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Surgi-Vision Inc, Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases
Keywords
Aorta, Atherosclerosis, MRI, statin, inflammatory markers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
72 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Simvastatin (20mg versus 80mg/day)
Primary Outcome Measure Information:
Title
change in aortic atherosclerotic plaque area and volume on transesophageal and surface MRI
Secondary Outcome Measure Information:
Title
serum levels of inflammatory markers like C-reactive Protein (CRP), Interleukin (IL-6), Tumor Necrosis Factor alpha(TNF-α)
Title
cardiovascular events and stroke during follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joao AC Lima, MD, MBA
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins - School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15646894
Citation
Steen H, Warren WP, Desai M, Gautam S, Lai S, Heath S, Stuber M, Lima JA. Combined transesophageal and surface MRI provides optimal imaging in aortic atherosclerosis. J Cardiovasc Magn Reson. 2004;6(4):909-16. doi: 10.1081/jcmr-200036202.
Results Reference
result
PubMed Identifier
15477398
Citation
Lima JA, Desai MY, Steen H, Warren WP, Gautam S, Lai S. Statin-induced cholesterol lowering and plaque regression after 6 months of magnetic resonance imaging-monitored therapy. Circulation. 2004 Oct 19;110(16):2336-41. doi: 10.1161/01.CIR.0000145170.22652.51. Epub 2004 Oct 11.
Results Reference
result
PubMed Identifier
18545070
Citation
Gottlieb I, Agarwal S, Gautam S, Desai M, Steen H, Warren WP, Xavier SS, Lima JA. Aortic plaque regression as determined by magnetic resonance imaging with high-dose and low-dose statin therapy. J Cardiovasc Med (Hagerstown). 2008 Jul;9(7):700-6. doi: 10.2459/JCM.0b013e3282f447c3.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs