Expired Study
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Charlottesville, Virginia 22908


Purpose:

Sixty patients with mild-to-moderate PAD (ABI 0.4-0.9) and hypertriglyceridemia (>200 mg/dl) already treated with statins will be imaged at baseline and randomized to Lovaza and placebo for 12 months. MR imaging will be repeated at the end of the 12-month period. We hypothesize that treatment of hypertriglyceridemia in patients with PAD with Lovaza will reduce atherosclerotic plaque volume in the superficial femoral artery (SFA) by 2% over 1 year compared to placebo. Secondary aims will be to show improved plaque characteristics (thickened fibrous cap, reduced lipid-rich necrotic core, improved exercise calf muscle perfusion using first-pass contrast enhanced MRI and improved exercise treadmill performance with Lovaza compared to matching placebo.


Criteria:

Inclusion Criteria: - Male or female, any ethnicity, ages 55-75 - Mild to moderate PAD (ankle brachial index (ABI) of 0.4-0.9 in either or both limbs) - Symptomatic intermittent claudication in either or both limbs - Hyperlipidemia treated with HMG-CoA reductase inhibition with persistent hypertriglyceridemia (triglycerides>200). Exclusion Criteria: - Patients with critical limb ischemia - Moderate to severe chronic kidney disease (requiring hemodialysis or glomerular filtration rate (GFR) < 45 ml/min) - Contraindication to MRI (pacemakers, defibrillators, intraocular metal, certain intracerebral aneurysm clips, etc.) - Claustrophobia - Known allergy to gadolinium chelates - Patients with iron storage disease


NCT ID:

NCT00569686


Primary Contact:

Principal Investigator
Christopher Kramer, MD
University of Virginia Health System


Backup Contact:

N/A


Location Contact:

Charlottesville, Virginia 22908
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 17, 2017

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