- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00125060
Transesophageal Magnetic Resonance Imaging (MRI) in Conjunction With Lipid Lowering Measures
Transesophageal MRI in Conjunction With Lipid Lowering Measures
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins - School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
change in aortic atherosclerotic plaque area and volume on transesophageal and surface MRI
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joao AC Lima, MD, MBA, Johns Hopkins University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-12-17-04
- M681-217-84250
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Diseases
-
Baker Heart and Diabetes InstitutePrincess Alexandra Hospital, Brisbane, Australia; Royal Perth Hospital; Alice... and other collaboratorsRecruitingHeart Failure | Valve Heart DiseaseAustralia
-
Medical University of ViennaUnknownHeart Diseases | Heart Failure | Valvular Heart DiseaseAustria
-
Centre Chirurgical Marie LannelongueActive, not recruitingValvular Heart Disease | Valve Disease, Heart
-
Kathirvel SubramaniamUniversity of Maryland, Baltimore; CSL BehringRecruitingHeart Failure,Congestive | Heart Disease End StageUnited States
-
University of MichiganTerminatedDiastolic Heart Failure | Hypertensive Heart DiseaseUnited States
-
Abiomed Inc.RecruitingHeart Diseases | Acute Decompensated Heart Failure | Congestive Heart Failure | Acute Heart FailureUnited States
-
Wuerzburg University HospitalRecruitingHeart Failure | Chronic Heart Failure | Chronic Heart DiseaseGermany
-
Yonsei UniversityCompletedMitral Valvular Heart Disease
-
Aristotle University Of ThessalonikiRecruitingCardiovascular Diseases | Heart Failure | Valvular Heart Disease | Biochemical DysfunctionGreece
-
University College, LondonBritish Heart Foundation; Horizon 2020 - European CommissionRecruitingValvular Heart DiseaseUnited Kingdom
Clinical Trials on Simvastatin (20mg versus 80mg/day)
-
University of Sao PauloCompletedCoronary Heart Disease
-
South China Center For Innovative PharmaceuticalsXiangya Hospital of Central South UniversityCompleted
-
Lipella Pharmaceuticals, Inc.William Beaumont HospitalsCompletedInterstitial CystitisUnited States
-
BeBetter Med IncCompleted
-
Linda Van EldikNational Institute on Aging (NIA); Duke Clinical Research InstituteCompleted
-
Glostrup University Hospital, CopenhagenLeiden University Medical CenterUnknown
-
CephalonCompletedPsoriasisUnited States
-
Victoria Arija ValCarlos III Health Institute; Catalan Institute of Health; University Rovira i... and other collaboratorsCompletedAnemia Ferropenic | Risk of Hemoconcentration (Iron Levels >130g/L)Spain
-
Cambridge University Hospitals NHS Foundation TrustUniversity of CambridgeActive, not recruitingCardiovascular Diseases | AtherosclerosisUnited Kingdom
-
Medicines for Malaria VentureUniversity of Cape TownCompleted