Comprehensive Magnetic Resonance of Peripheral Arterial Disease

University of Virginia

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Drug: Ezetimibe; Drug: Simvastatin; Drug: Simvastatin/Ezetimibe

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00587678

R01HL075792 (U.S. NIH Grant/Contract)

10387

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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85 participants in 2 patient groups

Randomized

Experimental group

Description:

Patients are imaged at baseline and randomized to Simvistatin 40 mg each night or Simvistatin 40mg/Zetia 10mg each night for 2 years

Treatment:

Drug: Simvastatin/Ezetimibe

Drug: Simvastatin

Ezetemibe

Experimental group

Description:

Patients are imaged at baseline and treated with ezetimibe 10mg each night for 2 years.

Treatment:

Drug: Ezetimibe