NCT00125060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2005

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

First QC Date

July 28, 2005

Last Update Submit

August 23, 2017

Conditions

Heart Diseases

Keywords

AortaAtherosclerosisMRIstatininflammatory markers

Outcome Measures

Primary Outcomes (1)

  • change in aortic atherosclerotic plaque area and volume on transesophageal and surface MRI

Secondary Outcomes (2)

  • 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

Interventions

Simvastatin (20mg versus 80mg/day)DRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins - School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (3)

  • 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.

    PMID: 15646894RESULT

  • 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.

    PMID: 15477398RESULT

  • 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.

    PMID: 18545070DERIVED

MeSH Terms

Conditions

Heart DiseasesAtherosclerosis

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Joao AC Lima, MD, MBA

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2005

First Posted

July 29, 2005

Study Start

August 1, 2000

Study Completion

April 1, 2004

Last Updated

August 24, 2017

Record last verified: 2017-08

Locations

US(1)