Carotid Plaque Regression With Statin Treatment Assessed by High Field Magnetic Resonance Imaging (MRI)

Withdrawn before enrolling

Conditions studied: Carotid Atherosclerosis

In brief

The purpose of the study is to determine if short term (6 months) treatment with statins to lower low-density lipoprotein (LDL) in vascular disease patients with carotid plaque will be associated with a measurable reduction in carotid plaque volume using 3 Tesla MRI. The researchers will correlate the change in plaque volume to degree of LDL lowering. The researchers will also study if brief treatment will lead to change in plaque composition. The researchers will compare the change in plaque volume measured by 3T MRI with plaque burden measured by ultrasound.

Key facts

Study ID

NCT00388843

Run by

Medical College of Wisconsin

People needed

0

Starts

2006-08-01

Expected to finish

2009-02-01

Last updated by the study team

2015-08-24

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult (> 21 years old) patients.
• Diagnosed with coronary artery disease or suspected cerebrovascular accident.
• For dose increased subjects, patients whose statin dose or LDL lowering therapy is doubled or increased from standard dose to high dose (see table).
• For dose maintained subjects, patients whose statin dose or LDL lowering therapy is maintained at standard dose (see table).
• Standard Dose (reported LDL↓ < 40% from literature)
• Drug Daily Dose/s: (md/day)
• atorvastatin 10
• simvastatin 5, 10, 20
• pravastatin 10, 20, 40, 80
• fluvastatin 20, 40, 80
• lovastatin 10, 20, 40
• High Dose (reported LDL↓ > 40% from literature)
• Drug Daily Dose/s (mg/day)
• atorvastatin 40, 80
• simvastatin 40, 80
• lovastatin 80
• rosuvastatin 5, 10, 20, 40
• Addition of non-statin lipid transfer (tx) (e.g., ezetimibe, fibrate, niacin) to standard statin dose

You may not qualify if…

• severe claustrophobia causing inability to undergo MRI implanted ferromagnetic materials (pacemakers, defibrillators, TENS units, aneurysm clips, etc.) that are not suitable for MRI in the clinical setting
• patients anticipated to undergo carotid stenting or surgery in next 6 months
• patients unable to lie flat for 1 hour
• patients requiring supplemental oxygen
• pregnant women
• patients who could not be followed up for 6 months

Where it is running

• Medical College of Wisconsin/Froedtert Memorial and Lutheran Hospital — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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