Comprehensive Magnetic Resonance of Peripheral Arterial Disease

Not Applicable

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Drug: Simvastatin; Drug: Ezetimibe; Drug: Simvastatin/Ezetimibe

• Registration Number: NCT00587678
• Lead Sponsor: University of Virginia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-07
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2011-08-02
• Results First Submitted QC: 2012-01-03
• Results First Posted: 2012-02-03
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-20
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized	Simvastatin/Ezetimibe	Patients are imaged at baseline and randomized to Simvistatin 40 mg each night or Simvistatin 40mg/Zetia 10mg each night for 2 years
Randomized	Simvastatin	Patients are imaged at baseline and randomized to Simvistatin 40 mg each night or Simvistatin 40mg/Zetia 10mg each night for 2 years
Ezetemibe	Ezetimibe	Patients are imaged at baseline and treated with ezetimibe 10mg each night for 2 years.

Primary Outcome Measures

Name	Time	Method
Plaque Volume	2 years	SFA plaque volume
Perfusion Index	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.	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

Name	Time	Method
Log Treadmill Exercise Time	2 years
6-minute Walk Distance	2 years
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	MRA index is a measure of angiographic severity of disease. 0 = no disease and 4 is severe disease.

Trial Locations

Locations (1)

University of Virgina Health System; 🇺🇸 Charlottesville, Virginia, United States