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Comprehensive Magnetic Resonance of Peripheral Arterial Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00587678
First Posted: January 7, 2008
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Christopher M. Kramer MD, University of Virginia
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comprehensive Magnetic Resonance of Peripheral Arterial Disease

Resource links provided by NLM:


Further study details as provided by Christopher M. Kramer MD, University of Virginia:

Primary Outcome Measures:
  • Plaque Volume [ Time Frame: 2 years ]
    SFA plaque volume

  • Perfusion Index [ Time Frame: 2 years ]
    Perfusion index is a MRI measure of calf muscle perfusion indexed to the arterial input. The value is between 0 and 1 with 0 being worst and 1 being best.

  • Phosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau. [ Time Frame: 2 years ]
    Phosphocreatine recovery time constant is the time it takes for phosphocreatine levels to recover to plateau after the completion of exercise. This ranges from 20 to 1000 seconds. 20-40 seconds is normal and any value over 40 seconds is abnormal.


Secondary Outcome Measures:
  • Low Density Lipoprotein Cholesterol [ Time Frame: 2 years ]
  • Total Cholesterol [ Time Frame: 2 years ]
  • High Density Lipoprotein Cholesterol [ Time Frame: 2 years ]
  • Triglycerides [ Time Frame: 2 years ]
  • Magnetic Resonance Angiographic Index [ Time Frame: 2 years ]
    MRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease.

  • Log Treadmill Exercise Time [ Time Frame: 2 years ]
  • 6-minute Walk Distance [ Time Frame: 2 years ]
  • V02 - Maximal Oxygen Consumption [ Time Frame: 2 years ]

Enrollment: 85
Study Start Date: January 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Randomized
Patients are imaged at baseline and randomized to Simvistatin 40 mg each night or Simvistatin 40mg/Zetia 10mg each night for 2 years
Drug: Simvastatin
40mg each night
Other Name: Zocor
Drug: Simvastatin/Ezetimibe
40mg/10mg each night
Other Name: Vytorin
Experimental: Ezetemibe
Patients are imaged at baseline and treated with ezetimibe 10mg each night for 2 years.
Drug: Ezetimibe
10mg daily
Other Name: Zetia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Christopher M Kramer, M.D. University of Virginia Health System
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christopher M. Kramer MD, Professor of Radiology and Medicine, University of Virginia
ClinicalTrials.gov Identifier: NCT00587678     History of Changes
Other Study ID Numbers: 10387
R01HL075792 ( U.S. NIH Grant/Contract )
First Submitted: December 21, 2007
First Posted: January 7, 2008
Results First Submitted: August 2, 2011
Results First Posted: February 3, 2012
Last Update Posted: August 21, 2017
Last Verified: July 2017

Keywords provided by Christopher M. Kramer MD, University of Virginia:
PAD

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Simvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors