Comprehensive Magnetic Resonance of Peripheral Arterial Disease

Study Overview
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Brief Summary
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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.

Official Title
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Comprehensive Magnetic Resonance of Peripheral Arterial Disease

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Drug: Simvastatin
* Drug: Ezetimibe
* Drug: Simvastatin/Ezetimibe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomized<br>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<br>* 40mg each night<br>* Other names: Zocor;Drug: Simvastatin/Ezetimibe<br>* 40mg/10mg each night<br>* Other names: Vytorin;|
| Experimental: Ezetemibe<br>Patients are imaged at baseline and treated with ezetimibe 10mg each night for 2 years. | Drug: Ezetimibe<br>* 10mg daily<br>* Other names: Zetia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Volume | SFA plaque volume | 2 years | 
| Perfusion Index | 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. | 2 years | 
| Phosphocreatine Recovery Time Constant - the Time it Takes for Phosphocreatine Levels to Recover to Plateau. | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Density Lipoprotein Cholesterol |  | 2 years | 
| Total Cholesterol |  | 2 years | 
| High Density Lipoprotein Cholesterol |  | 2 years | 
| Triglycerides |  | 2 years | 
| Magnetic Resonance Angiographic Index | MRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease. | 2 years | 
| Log Treadmill Exercise Time |  | 2 years | 
| 6-minute Walk Distance |  | 2 years | 
| V02 - Maximal Oxygen Consumption |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD