Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging

Johns Hopkins University

Status: Terminated

Conditions: Diabetes

Treatments: Drug: lipitor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00770679

NA00002253

Details and patient eligibility

About

Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. The investigators are testing whether statins improve endothelial function more in the arteries that have worse endothelium to begin with. One of the functions of the endothelium is to help control how blood vessels dilate (expand) or contract (narrow) in different situations. This affects how blood flows through those vessels. Magnetic resonance imaging (MRI) can be used to evaluate endothelial function in the arms and legs noninvasively.

Full description

Correct

Enrollment: 16 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 40-90
• Male or female
• Type 2 diabetes

Exclusion criteria

• Known pregnancy or nursing.
• Females of child bearing potential must have been surgically sterilized or be post menopausal.
• Smoking
• Known vascular disease
• Inability to complete MRI scan
• Symptoms of claudication
• Use of a nitrate medicine
• Use of any cholesterol-lowering agent
• LDL < 70
• Acute illness
• Liver disease
• Contraindication to getting an MRI scan (i.e. electronic implant, shrapnel, cerebral aneurysm clip, welding history).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

High-Dose Statin

Experimental group

Description:

80 mg atorvastatin daily for 3 weeks

Treatment:

Drug: lipitor