Comprehensive Magnetic Resonance of Peripheral Arterial Disease
Overview
- Phase
- Not Applicable
- Intervention
- Simvastatin/Ezetimibe
- Conditions
- Peripheral Artery Disease
- Sponsor
- University of Virginia
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Plaque Volume
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Christopher M. Kramer MD
Professor of Radiology and Medicine
University of Virginia
Eligibility 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
- •Lippincott, Williams and Wilkins
Arms & Interventions
Randomized
Patients are imaged at baseline and randomized to Simvistatin 40 mg each night or Simvistatin 40mg/Zetia 10mg each night for 2 years
Intervention: Simvastatin/Ezetimibe
Randomized
Patients are imaged at baseline and randomized to Simvistatin 40 mg each night or Simvistatin 40mg/Zetia 10mg each night for 2 years
Intervention: Simvastatin
Ezetemibe
Patients are imaged at baseline and treated with ezetimibe 10mg each night for 2 years.
Intervention: Ezetimibe
Outcomes
Primary Outcomes
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 Outcomes
- V02 - Maximal Oxygen Consumption(2 years)
- Low Density Lipoprotein Cholesterol(2 years)
- Total Cholesterol(2 years)
- High Density Lipoprotein Cholesterol(2 years)
- Triglycerides(2 years)
- Magnetic Resonance Angiographic Index(2 years)
- Log Treadmill Exercise Time(2 years)
- 6-minute Walk Distance(2 years)