Comprehensive Magnetic Resonance of Peripheral Arterial Disease

This study has been completed.
Sponsor:
Collaborator:
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

December 21, 2007
January 3, 2012
January 2006
October 2009   (final data collection date for primary outcome measure)
  • 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.
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 ]
Complete list of historical versions of study NCT00587678 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Comprehensive Magnetic Resonance of Peripheral Arterial Disease
Comprehensive Magnetic Resonance of Peripheral Arterial Disease

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Peripheral Artery Disease
  • Drug: Simvastatin
    40mg each night
    Other Name: Zocor
  • Drug: Ezetimibe
    10mg daily
    Other Name: Zetia
  • Drug: Simvastatin/Ezetimibe
    40mg/10mg each night
    Other Name: Vytorin
  • 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
    Interventions:
    • Drug: Simvastatin
    • Drug: Simvastatin/Ezetimibe
  • Experimental: Ezetemibe
    Patients are imaged at baseline and treated with ezetimibe 10mg each night for 2 years.
    Intervention: Drug: Ezetimibe

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
30 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587678
10387, R01 HL75792
No
Christopher M. Kramer MD, University of Virginia
University of Virginia
National Institutes of Health (NIH)
Principal Investigator: Christopher M Kramer, M.D. University of Virginia Health System
University of Virginia
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP