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Comprehensive Magnetic Resonance of Peripheral Arterial Disease

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Christopher M. Kramer MD, University of Virginia
ClinicalTrials.gov Identifier:
NCT00587678
First received: December 21, 2007
Last updated: January 3, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comprehensive Magnetic Resonance of Peripheral Arterial Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Plaque Volume [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    SFA plaque volume

  • Perfusion Index [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Total Cholesterol [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • High Density Lipoprotein Cholesterol [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Magnetic Resonance Angiographic Index [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 6-minute Walk Distance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • V02 - Maximal Oxygen Consumption [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

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:

Additional 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, R01 HL75792
Study First Received: December 21, 2007
Results First Received: August 2, 2011
Last Updated: January 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013