Status:
COMPLETED
Evaluate Carotid Artery Plaque Composition by Magnetic Resonance Imaging in People Receiving Cholesterol Medication
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Pfizer
Conditions:
Coronary Artery Disease
Carotid Artery Diseases
Eligibility:
All Genders
21-70 years
Phase:
PHASE4
Brief Summary
Atherosclerosis is a condition that occurs when fatty deposits build up along the inner walls of arteries. This study will examine the effectiveness of a combination of cholesterol-lowering medication...
Detailed Description
Atherosclerosis is a condition in which deposits of fat, cholesterol, and other substances build up along the inner walls of arteries; these deposits are known as plaque. People with atherosclerosis a...
Eligibility Criteria
Inclusion
- Clinically established coronary artery disease or carotid artery disease with greater than 15% stenosis by ultrasound
- Family history of cardiovascular disease
- Apolipoprotein B level greater than or equal to 120 mg/dL (LDL level should be between 100 and 190 mg/dL without medication)
- Has been undergoing lipid therapy for no more than 12 months before study entry
- Medically stable
- Medically able to undergo MRI procedure
Exclusion
- Uses pacemaker or has metallic implants
- Has immediate plans for carotid endarterectomy
- History of alcohol or drug abuse
- Active liver disease or liver dysfunction, defined by elevations in alanine aminotransferase (ALT)/aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal
- Serum creatine kinase (CK) level greater than 3 times the upper limit of normal before study entry
- Serum creatinine level greater than 2.5 times the upper limit of normal
- Diabetes, with a fasting glucose level greater than 150 mg/dL or hemoglobin A1c (HbA1c) level greater than 8% before study entry
- Uncontrolled high blood pressure, defined as average resting systolic blood pressure greater than 200 mm Hg or average resting diastolic blood pressure greater than 95 mm Hg
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT00715273
Start Date
May 1 2001
End Date
March 1 2019
Last Update
June 7 2022
Active Locations (4)
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1
University of Southern California
Los Angeles, California, United States, 90089
2
St. Luke's Idaho Cardiology
Boise, Idaho, United States, 83712
3
University of Washington Coronary Atherosclerosis Research Lab
Seattle, Washington, United States, 98104
4
Yakima Heart Center
Yakima, Washington, United States, 98902