Status:
WITHDRAWN
Carotid Plaque Regression With Statin Treatment Assessed by High Field Magnetic Resonance Imaging (MRI)
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Carotid Atherosclerosis
Eligibility:
All Genders
21+ years
Brief Summary
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...
Detailed Description
Atherosclerotic vascular disease is the leading cause of death in the United States. Atherosclerosis develops with increasing plaque burden and eccentric arterial wall expansion or remodeling, later l...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00388843
Start Date
August 1 2006
End Date
February 1 2009
Last Update
August 24 2015
Active Locations (1)
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1
Medical College of Wisconsin/Froedtert Memorial and Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226