Comprehensive Magnetic Resonance of Peripheral Arterial Disease - Full Text View

Sponsors and Collaborators:	University of Virginia National Institutes of Health (NIH)
Information provided by:	University of Virginia
ClinicalTrials.gov Identifier:	NCT00587678

Purpose

The purpose of this study is to develop new ways of imaging fatty blockages in the leg arteries to improve upon techniques used now and to develop new ways of understanding how new treatments may affect the disease.

Condition	Intervention
Peripheral Artery Disease	Drug: Simvastatin Drug: Ezetimibe Drug: Simvastatin/Ezetimibe

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Historical Control, Parallel Assignment, Efficacy Study
Official Title:	Comprehensive Magnetic Resonance of Peripheral Arterial Disease

Further study details as provided by University of Virginia:

Primary Outcome Measures:

We hypothesize that multi-modality magnetic resonance can test the efficacy of lipid lowering therapy therapy on the vessel wall, atherosclerotic plaque, and skeletal muscle perfusion and energetics in PAD [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment:	87
Study Start Date:	January 2006
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
R: Experimental Patients are imaged at baseline and randomized to Simvistatin 40 mg daily or Simvistatin 40mg/Zetia 10mg daily for 2 years	Drug: Simvastatin 40mg Drug: Simvastatin/Ezetimibe 40mg/10mg
Z: Experimental Patients are imaged at baseline and treated with ezetimibe 10mg for 2 years.	Drug: Ezetimibe 10mg

Eligibility

Ages Eligible for Study:	30 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients age 30-85 referred to the vascular imaging laboratory with documented evidence of peripheral arterial disease (0.4<ABI<0.9) 96 Normal healthy subjects ages 30-85

Exclusion Criteria:

Age<30, >85

GFR less than 45mL/min based on a serum creatinine drawn within 90 days of the MRI:

Pregnancy Contraindications to a magnetic resonance examination

Intracranial clips
Implantable pacemaker and defibrillator
Cochlear or intraocular implants
Claustrophobia
Any metallic implant not listed as magnetic resonance compatible in Shellock F.G ---Pocket Guide to Magnetic Resonance Procedures and Metallic Objects, Update 2000. Lippincott, Williams and Wilkins

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587678

Locations

United States, Virginia
University of Virgina Health System
Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

University of Virginia

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Christopher M Kramer, M.D.

University of Virginia Health System

More Information

Publications:

Isbell DC, Berr SS, Toledano AY, Epstein FH, Meyer CH, Rogers WJ, Harthun NL, Hagspiel KD, Weltman A, Kramer CM. Delayed calf muscle phosphocreatine recovery after exercise identifies peripheral arterial disease. J Am Coll Cardiol. 2006 Jun 6;47(11):2289-95. Epub 2006 May 15.

Isbell DC, Meyer CH, Rogers WJ, Epstein FH, DiMaria JM, Harthun NL, Wang H, Kramer CM. Reproducibility and reliability of atherosclerotic plaque volume measurements in peripheral arterial disease with cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2007;9(1):71-6. Erratum in: J Cardiovasc Magn Reson. 2007;9(3):629.

Isbell DC, Epstein FH, Zhong X, DiMaria JM, Berr SS, Meyer CH, Rogers WJ, Harthun NL, Hagspiel KD, Weltman A, Kramer CM. Calf muscle perfusion at peak exercise in peripheral arterial disease: measurement by first-pass contrast-enhanced magnetic resonance imaging. J Magn Reson Imaging. 2007 May;25(5):1013-20.

Kramer CM. Peripheral arterial disease assessment: wall, perfusion, and spectroscopy. Top Magn Reson Imaging. 2007 Oct;18(5):357-69.

Responsible Party:	University of Virginia Health System ( Christopher Kramer M.D. )
Study ID Numbers:	IRB HSR 10387, R01 HL75792
Study First Received:	December 21, 2007
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00587678 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Virginia:

PAD

Study placed in the following topic categories:

Antimetabolites
Peripheral Vascular Diseases
Simvastatin
Antilipemic Agents

Vascular Diseases
Ezetimibe
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Additional relevant MeSH terms:

Antimetabolites
Peripheral Vascular Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Vascular Diseases
Ezetimibe

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009